The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for The Howmedica Kinematic Knee System.
| Device ID | K792089 |
| 510k Number | K792089 |
| Device Name: | THE HOWMEDICA KINEMATIC KNEE SYSTEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | HOWMEDICA CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-10-17 |
| Decision Date | 1980-05-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327047752 | K792089 | 000 |
| 07613327046687 | K792089 | 000 |
| 07613327046618 | K792089 | 000 |
| 07613327046502 | K792089 | 000 |