The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Uhmwpe Hip And Knee Components - Packaging Change.
| Device ID | K964655 |
| 510k Number | K964655 |
| Device Name: | UHMWPE HIP AND KNEE COMPONENTS - PACKAGING CHANGE |
| 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 | JDL |
| 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 | 1996-11-20 |
| Decision Date | 1997-02-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04546540323163 | K964655 | 000 |
| 04546540319449 | K964655 | 000 |
| 04546540319432 | K964655 | 000 |
| 04546540319425 | K964655 | 000 |
| 04546540319418 | K964655 | 000 |
| 04546540319401 | K964655 | 000 |
| 04546540319395 | K964655 | 000 |
| 04546540319388 | K964655 | 000 |
| 04546540319371 | K964655 | 000 |
| 04546540319364 | K964655 | 000 |
| 04546540319357 | K964655 | 000 |
| 04546540319456 | K964655 | 000 |
| 04546540319463 | K964655 | 000 |
| 04546540323019 | K964655 | 000 |
| 04546540322869 | K964655 | 000 |
| 04546540319548 | K964655 | 000 |
| 04546540319531 | K964655 | 000 |
| 04546540319524 | K964655 | 000 |
| 04546540319517 | K964655 | 000 |
| 04546540319500 | K964655 | 000 |
| 04546540319494 | K964655 | 000 |
| 04546540319487 | K964655 | 000 |
| 04546540319470 | K964655 | 000 |
| 04546540319340 | K964655 | 000 |