The following data is part of a premarket notification filed by Kirschner Medical Corp. with the FDA for Kirschner(r) Hybridfit Total Knee System.
| Device ID | K913492 |
| 510k Number | K913492 |
| Device Name: | KIRSCHNER(R) HYBRIDFIT TOTAL KNEE SYSTEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | KIRSCHNER MEDICAL CORP. 9690 DEERECO ROADD Timonium, MD 21093 |
| Contact | Sam Son |
| Correspondent | Sam Son KIRSCHNER MEDICAL CORP. 9690 DEERECO ROADD Timonium, MD 21093 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-06 |
| Decision Date | 1991-12-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304340312 | K913492 | 000 |
| 00880304340305 | K913492 | 000 |
| 00880304340299 | K913492 | 000 |