The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Select Shoulder Pegged All-poly Glenoid.
Device ID | K962244 |
510k Number | K962244 |
Device Name: | SELECT SHOULDER PEGGED ALL-POLY GLENOID |
Classification | Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented |
Applicant | INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin, TX 78717 |
Contact | Mitchel A Dhority |
Correspondent | Mitchel A Dhority INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin, TX 78717 |
Product Code | KWT |
CFR Regulation Number | 888.3650 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-06-11 |
Decision Date | 1996-08-09 |
Summary: | summary |