The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Select(r) Shoulder All Poly Glenoid.
| Device ID | K935802 |
| 510k Number | K935802 |
| Device Name: | SELECT(R) SHOULDER ALL POLY GLENOID |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | INTERMEDICS ORTHOPEDICS 1300-C EAST ANDERSON LN. Austin, TX 78752 |
| Contact | Joann Ringer |
| Correspondent | Joann Ringer INTERMEDICS ORTHOPEDICS 1300-C EAST ANDERSON LN. Austin, TX 78752 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-02 |
| Decision Date | 1995-05-22 |