The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Osteolock(tm) Acetabular Cup.
| Device ID | K903362 |
| 510k Number | K903362 |
| Device Name: | OSTEOLOCK(TM) ACETABULAR CUP |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| 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 | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-26 |
| Decision Date | 1990-10-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327035759 | K903362 | 000 |
| 07613327035636 | K903362 | 000 |
| 07613327035643 | K903362 | 000 |
| 07613327035650 | K903362 | 000 |
| 07613327035667 | K903362 | 000 |
| 07613327035674 | K903362 | 000 |
| 07613327035681 | K903362 | 000 |
| 07613327035698 | K903362 | 000 |
| 07613327035704 | K903362 | 000 |
| 07613327035711 | K903362 | 000 |
| 07613327035728 | K903362 | 000 |
| 07613327035735 | K903362 | 000 |
| 07613327035742 | K903362 | 000 |
| 07613327035629 | K903362 | 000 |