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 |