The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Stryker Ibur Hubs And Cutting Accessories.
| Device ID | K210377 |
| 510k Number | K210377 |
| Device Name: | Stryker IBur Hubs And Cutting Accessories |
| Classification | Drills, Burrs, Trephines & Accessories (simple, Powered) |
| Applicant | Stryker Corporation 1941 Stryker Way Portage, MI 49002 |
| Contact | Alison Garrad |
| Correspondent | Alison Garrad Stryker 1941 Stryker Way Portage, 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 | 2021-02-09 |
| Decision Date | 2021-06-30 |