The following data is part of a premarket notification filed by Tornier with the FDA for Aequalis Universal Shoulder Glenoid.
Device ID | K994393 |
510k Number | K994393 |
Device Name: | AEQUALIS UNIVERSAL SHOULDER GLENOID |
Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
Applicant | TORNIER 200 GREGORY LN. SUITE C-100 Pleasant Hill, CA 94523 -3389 |
Contact | David W Schlerf |
Correspondent | David W Schlerf TORNIER 200 GREGORY LN. SUITE C-100 Pleasant Hill, CA 94523 -3389 |
Product Code | KWS |
CFR Regulation Number | 888.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-12-28 |
Decision Date | 2000-06-22 |
Summary: | summary |