The following data is part of a premarket notification filed by Stryker Craniomaxillofacial with the FDA for Stryker Twist Drills.
| Device ID | K070876 |
| 510k Number | K070876 |
| Device Name: | STRYKER TWIST DRILLS |
| Classification | Drills, Burrs, Trephines & Accessories (simple, Powered) |
| Applicant | STRYKER CRANIOMAXILLOFACIAL 750 TRADE CENTRE WAY SUITE 200 Kalamazoo, MI 49002 |
| Contact | Tennille Folk |
| Correspondent | Tennille Folk STRYKER CRANIOMAXILLOFACIAL 750 TRADE CENTRE WAY SUITE 200 Kalamazoo, MI 49002 |
| Product Code | HBE |
| CFR Regulation Number | 882.4310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-29 |
| Decision Date | 2007-04-27 |
| Summary: | summary |