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510(k) K132250

INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM by Integra LifeSciences Corporation — Product Code JWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2014
Date Received
July 19, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
Device Class
Class II
Regulation Number
888.3800
Review Panel
OR
Submission Type

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Other clearances for product code JWJ

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  • K200718 — Arthrosurface WristMotion Total Wrist Arthroplasty System (October 15, 2020)
  • K191525 — KinematX Total Wrist Arthroplasty System (March 4, 2020)
  • K080426 — MAESTRO WRIST FRACTURE IMPLANT (July 29, 2008)
  • K042032 — MAESTRO TOTAL WRIST (October 7, 2004)
  • K031203 — BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST (July 14, 2003)
  • K030037 — UNIVERSAL TOTAL WRIST SYSTEM (February 5, 2003)
  • K021859 — WRIST IMPLANT (December 2, 2002)