The following data is part of a premarket notification filed by Kirschner Medical Corp. with the FDA for Kirschner(r) Modular Ii-c(tm) Total Shoulder System.
| Device ID | K940537 |
| 510k Number | K940537 |
| Device Name: | KIRSCHNER(R) MODULAR II-C(TM) TOTAL SHOULDER SYSTEM |
| Classification | Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented |
| 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 | KWT |
| CFR Regulation Number | 888.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-07 |
| Decision Date | 1995-08-29 |