The following data is part of a premarket notification filed by Tornier, Inc. with the FDA for Perform Humeral System – Stem.
| Device ID | K201315 |
| 510k Number | K201315 |
| Device Name: | PERFORM Humeral System – Stem |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer + Additive, Cemented |
| Applicant | Tornier, Inc. 10801 Nesbitt Avenue South Bloomington, MN 55437 |
| Contact | Renee Stoffel |
| Correspondent | Renee Stoffel Tornier, Inc. 10801 Nesbitt Avenue South Bloomington, MN 55437 |
| Product Code | PAO |
| Subsequent Product Code | HSD |
| Subsequent Product Code | KWS |
| Subsequent Product Code | KWT |
| Subsequent Product Code | PHX |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-18 |
| Decision Date | 2020-09-11 |