BAGUERA® C Cervical Disc Surgical Instruments

{0} **U.S. FOOD & DRUG** ADMINISTRATION August 14, 2026 Spineart SA Estelle Godeau Regulatory Affairs & Market Access Director Chemin Du Pre-Fleuri 3 Plan-Les-Ouates, 1228 Switzerland Re: K262639 Trade/Device Name: BAGUERA® C Cervical Disc Surgical Instruments Regulation Number: 21 CFR 888.4515 Regulation Name: Orthopedic Manual Surgical Instrumentation For Use With Total Disc Replacement Devices Regulatory Class: Class II Product Code: QLQ Dated: July 29, 2026 Received: July 29, 2026 Dear Estelle Godeau: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1} K262639 - Estelle Godeau Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the {2} K262639 - Estelle Godeau Page 3 Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, MAZIAR SHAH-MOHAMMADI - S Maziar ShahMohammadi, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K262639 | ? | | Please provide the device trade name(s). | | ? | | BAGUERA® C Cervical Disc Surgical Instruments | | | | Please provide your Indications for Use below. | | ? | | The BAGUERA C Cervical Disc Surgical Instruments are intended for the placement, positioning, and removal of the BAGUERA C Cervical Disc Prosthesis. | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | | Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☐ Adults (22 years old and greater) | ? | {4} K262639- Page 1 of 2 # **510(k) SUMMARY** **Device Trade Name:** BAGUERA® C Cervical Disc Surgical Instruments **Manufacturer:** Spineart SA Chemin du Pré-Fleuri 3 1228 Plan-Les-Ouates Switzerland **Contact:** Estelle GODEAU Regulatory Affairs & Market Access Director Phone: +41 22 570 1203 Fax: +41 22 594 8306 E-Mail: elefeuvre@spineart.com **Date Prepared:** July 29, 2026 **Classification:** 21 CFR §888.4515 **Classification Name:** Orthopedic Manual Surgical Instrument For Use With Total Disc Replacement Devices **Class:** II **Product Codes:** QLQ # **Indications for Use:** The BAGUERA® C Cervical Disc Surgical Instruments are intended for the placement, positioning, and removal of the BAGUERA® C Cervical Disc Prosthesis. # **Device Description:** The BAGUERA® C Cervical Disc Surgical Instruments are a collection of reusable instruments designed for use with the BAGUERA® C Cervical Disc during implantation procedure and, if necessary, device removal. Spineart Reusable Surgical Instruments and implants are not compatible with implants or instruments from other manufacturers unless otherwise specified. # **Primary Predicate Device:** Centinel Spine prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments (K221848) # **Performance Testing:** Testing included user testing, dimension analysis, cleaning validation, and steam sterilization. All completed tests met the pre-determined acceptance criteria. # **Substantial Equivalence:** {5} K262639- Page 2 of 2 The subject devices were demonstrated to be substantially equivalent to the predicate cited with respect to the indications, design, materials, function, and performance. # **Conclusion:** The subject device and the predicate device have the same intended use, have similar technological characteristics, and are made of similar materials. The information included in this submission demonstrates substantial equivalence to the predicate device listed above.