The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Hip Fracture Stem Fenestration Plug.
| Device ID | K953067 |
| 510k Number | K953067 |
| Device Name: | HIP FRACTURE STEM FENESTRATION PLUG |
| Classification | Prosthesis, Hip, Femoral Component, Cemented, Metal |
| Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | Mary C Spicer |
| Correspondent | Mary C Spicer HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Product Code | JDG |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-30 |
| Decision Date | 1995-08-21 |