The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Intermedics Select Shoulder Metal-backed Glenoid.
| Device ID | K884943 |
| 510k Number | K884943 |
| Device Name: | INTERMEDICS SELECT SHOULDER METAL-BACKED GLENOID |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752 |
| Contact | Thomas L Craig |
| Correspondent | Thomas L Craig INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-25 |
| Decision Date | 1989-04-27 |