ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)— 510(k) K181742
Substantially EquivalentStryker GmbH
FDA 510(k) clearance K181742 for ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA), Substantially Equivalent on 2018-09-27. Applicant: Stryker GmbH.
Clearance details
- Applicant
- Stryker GmbH
- Product code
- Code KWS
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mahwah, NJ, US
Adverse events under product code KWS
product code KWS- Death
- 6
- Injury
- 9,652
- Malfunction
- 1,385
- Other
- 1
- Total
- 11,044
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.