The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Howmedica Kinematic Ii Modular Tibial Component.
| Device ID | K871349 |
| 510k Number | K871349 |
| Device Name: | HOWMEDICA KINEMATIC II MODULAR TIBIAL COMPONENT |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| 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 | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-06 |
| Decision Date | 1987-09-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327046663 | K871349 | 000 |
| 07613327046526 | K871349 | 000 |
| 07613327046519 | K871349 | 000 |
| 07613327046496 | K871349 | 000 |
| 07613327046489 | K871349 | 000 |
| 07613327046472 | K871349 | 000 |
| 07613327046465 | K871349 | 000 |
| 07613327046458 | K871349 | 000 |
| 07613327046441 | K871349 | 000 |
| 07613327046533 | K871349 | 000 |
| 07613327046540 | K871349 | 000 |
| 07613327046649 | K871349 | 000 |
| 07613327046632 | K871349 | 000 |
| 07613327046625 | K871349 | 000 |
| 07613327046595 | K871349 | 000 |
| 07613327046588 | K871349 | 000 |
| 07613327046571 | K871349 | 000 |
| 07613327046564 | K871349 | 000 |
| 07613327046557 | K871349 | 000 |
| 07613327046427 | K871349 | 000 |