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 | K931114 |
| 510k Number | K931114 |
| Device Name: | SELECT(R) SHOULDER ALL-POLY GLENOID |
| Classification | Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented |
| Applicant | INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752 |
| Contact | Joann Ringer |
| Correspondent | Joann Ringer INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752 |
| Product Code | KWT |
| CFR Regulation Number | 888.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-04 |
| Decision Date | 1994-05-09 |