The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Stryker Total Performance System.
| Device ID | K943589 |
| 510k Number | K943589 |
| Device Name: | STRYKER TOTAL PERFORMANCE SYSTEM |
| Classification | Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment |
| Applicant | STRYKER CORP. 4100 E MILHAM AVE. Portage, MI 49002 -9704 |
| Contact | Tammy Lounds |
| Correspondent | Tammy Lounds STRYKER CORP. 4100 E MILHAM AVE. Portage, MI 49002 -9704 |
| Product Code | HWE |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-22 |
| Decision Date | 1994-12-15 |