The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Stryker Hermes-ready Total Performance System.
| Device ID | K991696 |
| 510k Number | K991696 |
| Device Name: | STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM |
| Classification | Drill, Bone, Powered |
| Applicant | STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Nicole Petty |
| Correspondent | Nicole Petty STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Product Code | DZI |
| Subsequent Product Code | EIA |
| Subsequent Product Code | ERL |
| Subsequent Product Code | HBC |
| Subsequent Product Code | HBE |
| Subsequent Product Code | HWE |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-18 |
| Decision Date | 1999-10-25 |
| Summary: | summary |