The following data is part of a premarket notification filed by Kirschner Medical Corp. with the FDA for Line Extension For Kirschner Performance Total Knee System, Porous Coated.
| Device ID | K933843 |
| 510k Number | K933843 |
| Device Name: | LINE EXTENSION FOR KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM, POROUS COATED |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | KIRSCHNER MEDICAL CORP. 20-01 POLLITT DR. Fair Lawn, NJ 07410 |
| Contact | Jacquelyn A Hughes |
| Correspondent | Jacquelyn A Hughes KIRSCHNER MEDICAL CORP. 20-01 POLLITT DR. Fair Lawn, NJ 07410 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-06 |
| Decision Date | 1994-08-05 |