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FDA 510(k)

Freedom Wrist Arthroplasty System

K-Number: K233674 · 2024-05-30

ApplicantAscension Orthopedics, Inc.
Decision Date2024-05-30
Product CodeJWJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Freedom Wrist Arthroplasty System is a medical device manufactured by Ascension Orthopedics, Inc.. It received FDA 510(k) clearance on 2024-05-30 under approval number K233674. 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 Freedom Wrist Arthroplasty System?

Freedom Wrist Arthroplasty System is a medical device that received FDA 510(k) clearance on 2024-05-30. It is manufactured by Ascension Orthopedics, Inc.. The 510(k) number is K233674.

When was Freedom Wrist Arthroplasty System approved by the FDA?

Freedom Wrist Arthroplasty System received FDA 510(k) clearance on 2024-05-30, under approval number K233674.

What company makes Freedom Wrist Arthroplasty System?

Freedom Wrist Arthroplasty System is manufactured by Ascension Orthopedics, Inc..

What is the FDA product code for Freedom Wrist Arthroplasty System?

The FDA product code for Freedom Wrist Arthroplasty System is JWJ.

Related Clinical Trials

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Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026)

Other Devices by Ascension Orthopedics, Inc.

K233670Ascension Silicone MCP; Ascension Silicone PIP

Related Devices (Code: JWJ)

K200718Arthrosurface WristMotion Total Wrist Arthroplasty SystemArthrosurface, Inc. K191525KinematX Total Wrist Arthroplasty SystemExtremity Medical, LLC K243381Total Wrist Arthroplasty System (TWA)Skeletal Dynamics, Inc. K233574Total Wrist Arthroplasty System (TWA)Skeletal Dynamics

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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