The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Duration Stabilized Uhmwpe.
| Device ID | K963612 |
| 510k Number | K963612 |
| Device Name: | DURATION STABILIZED UHMWPE |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | John Dichiara |
| Correspondent | John Dichiara HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Product Code | JDI |
| Subsequent Product Code | HRY |
| Subsequent Product Code | JWH |
| Subsequent Product Code | LPH |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-10 |
| Decision Date | 1997-06-11 |
| Summary: | summary |