The following data is part of a premarket notification filed by Orthopaedic Medical Group, Inc. with the FDA for Non Constrained Total Shoulder System.
| Device ID | K895802 |
| 510k Number | K895802 |
| Device Name: | NON CONSTRAINED TOTAL SHOULDER SYSTEM |
| Classification | Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented |
| Applicant | ORTHOPAEDIC MEDICAL GROUP, INC. 2400 WESTBOROUGH BLVD. SUITE 202 South San Francisco, CA 94080 |
| Contact | Stroot, Md |
| Correspondent | Stroot, Md ORTHOPAEDIC MEDICAL GROUP, INC. 2400 WESTBOROUGH BLVD. SUITE 202 South San Francisco, CA 94080 |
| 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 | 1989-09-28 |
| Decision Date | 1989-12-27 |