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 |