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FDA 510(k)

Total Wrist Arthroplasty System (TWA)

K-Number: K233574 · 2024-07-03

ApplicantSkeletal Dynamics
Decision Date2024-07-03
Product CodeJWJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Total Wrist Arthroplasty System (TWA) is the device name listed in this FDA 510(k) record. The listed applicant is Skeletal Dynamics. It received FDA 510(k) clearance on 2024-07-03 under 510(k) number K233574. The device is classified under product code JWJ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Total Wrist Arthroplasty System (TWA)?

Total Wrist Arthroplasty System (TWA) is a medical device that received FDA 510(k) clearance on 2024-07-03. The listed applicant is Skeletal Dynamics. The 510(k) number is K233574.

When did Total Wrist Arthroplasty System (TWA) receive FDA 510(k) clearance?

Total Wrist Arthroplasty System (TWA) received FDA 510(k) clearance on 2024-07-03, under 510(k) number K233574.

Who is the listed applicant for Total Wrist Arthroplasty System (TWA)?

The FDA 510(k) record lists Skeletal Dynamics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Total Wrist Arthroplasty System (TWA)?

The FDA product code for Total Wrist Arthroplasty System (TWA) is JWJ.

Other records listing Skeletal Dynamics as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261770Suture Button Repair SystemK254288Clavicle Fixation SystemK252949Geminus Volar Distal Radius Plating SystemK242436Proximal Humerus Fixation SystemK243381Total Wrist Arthroplasty System (TWA)K241815Protean Fragment Plating System

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Related Devices (Code: JWJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243381Total Wrist Arthroplasty System (TWA)Skeletal Dynamics, Inc.K233674Freedom Wrist Arthroplasty SystemAscension Orthopedics, Inc.K200718Arthrosurface WristMotion Total Wrist Arthroplasty SystemArthrosurface, Inc.K191525KinematX Total Wrist Arthroplasty SystemExtremity Medical, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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