The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Stryker Femoral Canal Sponge & Acetabulum Sponge.
| Device ID | K955599 |
| 510k Number | K955599 |
| Device Name: | STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE |
| Classification | Gauze/sponge, Internal, X-ray Detectable |
| Applicant | STRYKER CORP. 2725 FAIRFIELD RD. P.O. BOX 4085 Kalamazoo, MI 49003 -4085 |
| Contact | Tammy Lounds |
| Correspondent | Tammy Lounds STRYKER CORP. 2725 FAIRFIELD RD. P.O. BOX 4085 Kalamazoo, MI 49003 -4085 |
| Product Code | GDY |
| CFR Regulation Number | 878.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-08 |
| Decision Date | 1996-02-22 |