Total Wrist Arthroplasty System (TWA)— 510(k) K233574

Substantially Equivalent

Skeletal Dynamics

FDA 510(k) clearance K233574 for Total Wrist Arthroplasty System (TWA), Substantially Equivalent on 2024-07-03. Applicant: Skeletal Dynamics.

Clearance details

Applicant: Skeletal Dynamics
Product code: Code JWJ
Advisory panel: Orthopedic
Date received: 2023-11-07
Decision date: 2024-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JWJ

product code JWJ

Injury: 181
Total: 181

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.