The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Howmedica Precis Osteolock Fem Comp W/hydro Coat.
| Device ID | K912395 |
| 510k Number | K912395 |
| Device Name: | HOWMEDICA PRECIS OSTEOLOCK FEM COMP W/HYDRO COAT |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | Robert E Smith |
| Correspondent | Robert E Smith HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-28 |
| Decision Date | 1991-07-24 |