The following data is part of a premarket notification filed by Tornier, Inc. with the FDA for Tornier Perform™ Patient-matched Primary Reversed Glenoid And Blueprint™ Patient Specific Instrumentation.
Device ID | K211359 |
510k Number | K211359 |
Device Name: | Tornier Perform™ Patient-Matched Primary Reversed Glenoid And BLUEPRINT™ Patient Specific Instrumentation |
Classification | Shoulder Prosthesis, Reverse Configuration |
Applicant | Tornier, Inc. 10801 Nesbitt Ave South Bloomington, MN 55437 |
Contact | Lisa Stahl |
Correspondent | Lisa Stahl Tornier, Inc. 10801 Nesbitt Ave South Bloomington, MN 55437 |
Product Code | PHX |
Subsequent Product Code | KWS |
Subsequent Product Code | QHE |
CFR Regulation Number | 888.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-05-03 |
Decision Date | 2021-11-12 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
03700434015904 | K211359 | 000 |
03700434015898 | K211359 | 000 |
03700434015881 | K211359 | 000 |
03700434015874 | K211359 | 000 |
03700434015867 | K211359 | 000 |