The following data is part of a premarket notification filed by 3m Company with the FDA for Neer Ii Total Shoulder System & Prosthesis.
| Device ID | K895226 |
| 510k Number | K895226 |
| Device Name: | NEER II TOTAL SHOULDER SYSTEM & PROSTHESIS |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | 3M COMPANY CHEMOLITE BLVD. & WASHINGTON CITY RD. 19 Cottae Grove, MN 55016 |
| Contact | D Larson,phd |
| Correspondent | D Larson,phd 3M COMPANY CHEMOLITE BLVD. & WASHINGTON CITY RD. 19 Cottae Grove, MN 55016 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-14 |
| Decision Date | 1989-11-03 |