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 (rsa), Reunion Total Shoulder Arthroplasty (tsa).
| Device ID | K161863 |
| 510k Number | K161863 |
| Device Name: | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA) |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | Stryker GmbH Bohnackerweg 1 2545 Selzach, CH Ch 2545 |
| Contact | Saad Attiyah |
| Correspondent | Saad Attiyah Stryker GmbH Bohnackerweg 1 2545 Selzach, CH Ch 2545 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-06 |
| Decision Date | 2016-11-23 |