The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Precision Osteolock Femoral Comp. Titanium Plasma.
| Device ID | K896853 |
| 510k Number | K896853 |
| Device Name: | PRECISION OSTEOLOCK FEMORAL COMP. TITANIUM PLASMA |
| Classification | Prosthesis, Hip, Hemi-, Femoral, 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 | KWL |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-05 |
| Decision Date | 1990-05-02 |