The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Howmedica Femoral & Proximal Tibial Modular Replacement Sytesm.
| Device ID | K952970 |
| 510k Number | K952970 |
| Device Name: | HOWMEDICA FEMORAL & PROXIMAL TIBIAL MODULAR REPLACEMENT SYTESM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| 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 | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-27 |
| Decision Date | 1996-01-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327049817 | K952970 | 000 |
| 07613327048391 | K952970 | 000 |
| 07613327048407 | K952970 | 000 |
| 07613327048629 | K952970 | 000 |
| 07613327048636 | K952970 | 000 |
| 07613327048643 | K952970 | 000 |
| 07613327048650 | K952970 | 000 |
| 07613327048674 | K952970 | 000 |
| 07613327049770 | K952970 | 000 |
| 07613327049794 | K952970 | 000 |
| 07613327047745 | K952970 | 000 |