The following data is part of a premarket notification filed by Tornier, Inc. with the FDA for Tornier Perform Humeral System – Stemless.
| Device ID | K220418 |
| 510k Number | K220418 |
| Device Name: | Tornier Perform Humeral System – Stemless |
| Classification | Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained |
| Applicant | Tornier, Inc. 10801 Nesbitt Ave South Bloomington, MN 55437 |
| Contact | Renee Stoffel |
| Correspondent | Renee Stoffel Tornier, Inc. 10801 Nesbitt Ave South Bloomington, MN 55437 |
| Product Code | PKC |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-14 |
| Decision Date | 2022-09-14 |