The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Select Shoulder Curved-back Pegged All Poly Glenoids.
Device ID | K970567 |
510k Number | K970567 |
Device Name: | SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS |
Classification | Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented |
Applicant | INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin, TX 78717 |
Contact | Mitchell A Dhority |
Correspondent | Mitchell A Dhority INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin, TX 78717 |
Product Code | KWT |
CFR Regulation Number | 888.3650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-02-13 |
Decision Date | 1997-02-27 |
Summary: | summary |