The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Stryker Total Performance System.
| Device ID | K943569 |
| 510k Number | K943569 |
| Device Name: | STRYKER TOTAL PERFORMANCE SYSTEM |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | STRYKER CORP. 4100 E. MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Tammy Lounds |
| Correspondent | Tammy Lounds STRYKER CORP. 4100 E. MILHAM AVE. Kalamazoo, MI 49001 |
| Product Code | ERL |
| CFR Regulation Number | 874.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-22 |
| Decision Date | 1995-01-09 |