Total Wrist Arthroplasty System (TWA)— 510(k) K243381

Substantially Equivalent

Skeletal Dynamics, Inc.

FDA 510(k) clearance K243381 for Total Wrist Arthroplasty System (TWA), Substantially Equivalent on 2024-11-01. Applicant: Skeletal Dynamics, Inc..

Clearance details

Applicant: Skeletal Dynamics, Inc.
Product code: Code JWJ
Advisory panel: Orthopedic
Date received: 2024-10-30
Decision date: 2024-11-01
Decision: Substantially Equivalent
Clearance type: Special
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.