The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Duracon Cs Tibial Insert.
| Device ID | K021451 |
| 510k Number | K021451 |
| Device Name: | DURACON CS TIBIAL INSERT |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Contact | Margaret F Crowe |
| Correspondent | Margaret F Crowe HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-06 |
| Decision Date | 2002-10-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327049701 | K021451 | 000 |
| 07613327049558 | K021451 | 000 |
| 07613327049541 | K021451 | 000 |
| 07613327049534 | K021451 | 000 |
| 07613327049527 | K021451 | 000 |
| 07613327049510 | K021451 | 000 |
| 07613327049503 | K021451 | 000 |
| 07613327049497 | K021451 | 000 |
| 07613327049473 | K021451 | 000 |
| 07613327049466 | K021451 | 000 |
| 07613327049459 | K021451 | 000 |
| 07613327049442 | K021451 | 000 |
| 07613327049435 | K021451 | 000 |
| 07613327049565 | K021451 | 000 |
| 07613327049572 | K021451 | 000 |
| 07613327049695 | K021451 | 000 |
| 07613327049688 | K021451 | 000 |
| 07613327049671 | K021451 | 000 |
| 07613327049664 | K021451 | 000 |
| 07613327049657 | K021451 | 000 |
| 07613327049640 | K021451 | 000 |
| 07613327049633 | K021451 | 000 |
| 07613327049626 | K021451 | 000 |
| 07613327049619 | K021451 | 000 |
| 07613327049602 | K021451 | 000 |
| 07613327049596 | K021451 | 000 |
| 07613327049589 | K021451 | 000 |
| 07613327049428 | K021451 | 000 |