STRYKER LEIBINGER SKELETAL ANCHORING SYSTEM

{0}------------------------------------------------ # \$50 \$ 0 2016 #### 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS: Stryker® Leibinger Skeletal Anchoring System OnyxCeph\u00ae Ectoiniger Skeletal Anchor K041651 | General Information | | |--------------------------------|------------------------------------------------------------------------------------------| | Proprietary Name: | Stryker® Leibinger Skeletal Anchoring System | | Common Name: | Endosseous Implant | | Proposed Regulatory Class: | Class III | | Device Classification: | DZE (872.3640) | | Submitter: | Stryker Leibinger<br>4100 East Milham Avenue<br>Kalamazoo, MI 49001<br>269-323-4226 | | Submitter's Registration #: | 1811755 | | Manufacturer's Registration #: | 8010177 | | Contact Person: | Wade T. Rutkoskie<br>Associate Manager RA QA<br>Phone: 269-323-4226<br>Fax: 269-323-4215 | | Summary Preparation Date: | June 4, 2004 | #### Intended Usc The Stryker® Leibinger Universal Skcletal Anchoring System is a plating system intended to he placed in the mouth f be placed in the mouth for use as an anchor in orthodontic procedures. ## Substantial Equivalency Information The Stryker® Leibinger Skeletal Anchoring System is substantially equivalent to legally marketed K033483 KLS-Martin Ortho Anchorage System is Substantially Tequivalent for System. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular and contains the department's logo, which is a stylized caduceus. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the top and left side of the circle. #### Public Health Service SEP 3 0 2004 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Wade T. Rutkoskie Regulatory Affairs Associate Stryker Instruments 4100 East Milham Avenue Kalamazoo, Michigan 49024 Re: K041651 Trade/Device Name: Stryker Leibinger Skeletal Anchoring System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: September 21, 2004 Received: September 23, 2004 Dear Mr. Rutkoskie: 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 (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. 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. {2}------------------------------------------------ Page 2 - Mr. Rutkoskie 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Cure Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K041651 Device Name: Stryker Leibinger Skeletal Anchoring System Indications For Use: The Stryker Leibinger Skeletal Anchoring System is a plating system intended to be placed in the mouth, for use as an anchor in orthodontic procedures. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Robert S. Botros, M.D. Susan Renner Division Director y, General Hospital, Division of Anesthesiolo Infection Control, Dental I 510(k) Number: K04165