The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Intermedics Select Shoulder All Plastic Glen. Comp.
| Device ID | K881836 |
| 510k Number | K881836 |
| Device Name: | INTERMEDICS SELECT SHOULDER ALL PLASTIC GLEN. COMP |
| 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 (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-02 |
| Decision Date | 1988-08-29 |