510(k) K202289
K202289 is an FDA 510(k) premarket notification submitted by Stryker GmbH for the device "ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)". The FDA issued a decision of Substantially Equivalent on Dec 16, 2020. The device falls under product code KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented), a Class II device regulated under 21 CFR 888.3660. Stryker GmbH has 270 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 16, 2020
- Date Received
- Aug 12, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- Device Class
- Class II
- Regulation Number
- 888.3660
- Review Panel
- OR
- Submission Type
- 510(k)