The following data is part of a premarket notification filed by Kirschner Medical Corp. with the FDA for Neer-iii Solid Keel Glenoid Resurfacing Prosthesis.
| Device ID | K873621 |
| 510k Number | K873621 |
| Device Name: | NEER-III SOLID KEEL GLENOID RESURFACING PROSTHESIS |
| Classification | Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented |
| 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 | KWT |
| CFR Regulation Number | 888.3650 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-08 |
| Decision Date | 1987-10-15 |