The following data is part of a premarket notification filed by Kirschner Medical Corp. with the FDA for Kirschner Unicompartmental Knee System.
| Device ID | K894068 |
| 510k Number | K894068 |
| Device Name: | KIRSCHNER UNICOMPARTMENTAL KNEE SYSTEM |
| Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, 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 | HSX |
| CFR Regulation Number | 888.3520 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-08 |
| Decision Date | 1989-12-08 |