STRYKER TWIST DRILLS

{0}------------------------------------------------ # 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS: Stryker® Twist Drills #### General Information # APR 2 7 2007 | Proprietary Name: | Stryker® Twist Drills | |--------------------------------|-----------------------------------------------------------------------------------------------------------------| | Common Name: | Drills, Burrs, Trephines, and Accessories | | Proposed Regulatory Class: | Class II | | Device Classification: | HBE (21 CFR 882.4310) Powered simple cranial drills, burrs, trephines, and their accessories | | Submitter: | Stryker® Craniomaxillofacial<br>750 Trade Centre Way<br>Suite 200<br>Kalamazoo, MI 49002<br>877-534-2464 x 4250 | | Submitter's Registration #: | 3005101424 | | Manufacturer's Registration #: | 8010177 | | Contact Person: | Tennille Folk<br>Regulatory Affairs Representative<br>Phone: 877-534-2464 x 4250<br>Fax: 269-323-4215 | | Summary Preparation Date: | March 13, 2007 | #### Intended Use The Stryker® Twist Drills are intended to be used for drilling holes in large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures. ### Substantial Equivalency Information Stryker® considers the Stryker® Twist Drills equivalent to the existing Twist drills which are classified as class I devices. Stryker® Twist Drills are also equivalent to Stryker 75K Straight Drill K943541, Stryker Oral Max System K954690 and Lorenz Twist Drills K062842. {1}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol, with three curved lines forming its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circle, with "DEPARTMENT OF HEALTH" at the bottom, "& HUMAN SERVICES" on the left side, and "- USA" at the top. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Stryker Craniomaxillofacial % Ms. Tennille Folk Regulatory Affairs Representative 750 Trade Centre Way, Suite 200 Portage, Michigan 49002 APR 2 7 2007 Re: K070876 Trade/Device Name: Stryker® Twist Drills Regulation Number: 21 CFR 882.4310 Regulation Name: Powered simple cranial drills, burrs, trephines, and their accessories Regulatory Class: II Product Code: HBE Dated: April 12, 2007 Received: April 17, 2007 Dear Ms. Folk: 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. 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. {2}------------------------------------------------ Page 2 - Ms. Tennille Folk 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Mark N. Melkerson Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ### 510(K) Number (if known): K # Device Name: Stryker® Twist Drills ### Indications for Use: The Stryker® Twist Drills are intended to be used for drilling holes in large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures. | Prescription Use | X | AND/OR Over-the-Counter | |------------------------|---|-------------------------| | Use | | | | (21 CFR 801 Subpart D) | | (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) Page estorative, (Posted Novemb 510(k) Nul