Total Wrist Arthroplasty System (TWA)

by Skeletal Dynamics 510(k)

Active United States

510(k) K233574

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK233574	Date3 Jul 2024Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number: K233574
FDA Product Code: JWJ

Device Class: Class II
Regulation: 21 CFR Part 888.3800
Advisory Committee: Orthopedic
FDA Decision: SESE Substantially Equivalent

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