The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Modular Rotating Hinge Knee Crossover Tibial Bearing Components.
| Device ID | K001548 |
| 510k Number | K001548 |
| Device Name: | MODULAR ROTATING HINGE KNEE CROSSOVER TIBIAL BEARING COMPONENTS |
| Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| Applicant | HOWMEDICA OSTEONICS CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 -2584 |
| Contact | Jennifer A Daudelin |
| Correspondent | Jennifer A Daudelin HOWMEDICA OSTEONICS CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 -2584 |
| Product Code | KRO |
| CFR Regulation Number | 888.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-18 |
| Decision Date | 2000-06-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327045239 | K001548 | 000 |
| 07613327047547 | K001548 | 000 |
| 07613327047530 | K001548 | 000 |
| 07613327047523 | K001548 | 000 |
| 07613327047516 | K001548 | 000 |
| 07613327047509 | K001548 | 000 |
| 07613327047493 | K001548 | 000 |
| 07613327047486 | K001548 | 000 |
| 07613327047479 | K001548 | 000 |
| 07613327047462 | K001548 | 000 |
| 07613327047554 | K001548 | 000 |
| 07613327047561 | K001548 | 000 |
| 07613327045222 | K001548 | 000 |
| 07613327101102 | K001548 | 000 |
| 07613327047646 | K001548 | 000 |
| 07613327047622 | K001548 | 000 |
| 07613327047615 | K001548 | 000 |
| 07613327047608 | K001548 | 000 |
| 07613327047592 | K001548 | 000 |
| 07613327047585 | K001548 | 000 |
| 07613327047578 | K001548 | 000 |
| 07613327047455 | K001548 | 000 |