The following data is part of a premarket notification filed by Stryker Gmbh with the FDA for Reunion Reversible Fracture System (rfx), Reunion Reverse Shoulder Arthroplasty System (rsa), Reunion Total Shoulder Arthroplasty System (tsa).
| Device ID | K181742 |
| 510k Number | K181742 |
| Device Name: | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | Stryker GmbH 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Tina Mornak |
| Correspondent | Tina Mornak Stryker GmbH 325 Corporate Drive Mahwah, NJ 07430 |
| Product Code | KWS |
| Subsequent Product Code | HSD |
| Subsequent Product Code | PHX |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-02 |
| Decision Date | 2018-09-27 |