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510(k) K233574

Device
Total Wrist Arthroplasty System (TWA)
Applicant
Skeletal Dynamics
510(k) number
K233574
Product code
JWJ
Decision
Substantially Equivalent (SESE)
Decision date
2024-07-03
Date received
2023-11-07
Regulation
888.3800
Classification name
Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Alexandra Rodriguez
Address
7300 N Kendall Dr. Miami FL US 33156 33156

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JWJ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243381Total Wrist Arthroplasty System (TWA)Skeletal Dynamics, Inc.2024-11-01
K233674Freedom Wrist Arthroplasty SystemAscension Orthopedics, Inc.2024-05-30
K200718Arthrosurface WristMotion Total Wrist Arthroplasty SystemArthrosurface, Inc.2020-10-15
K191525KinematX Total Wrist Arthroplasty SystemExtremity Medical, LLC2020-03-04
K132250INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEMIntegra LifeSciences Corporation2014-03-24
K080426MAESTRO WRIST FRACTURE IMPLANTBiomet Manufacturing Corp2008-07-29
K042032MAESTRO TOTAL WRISTBiomet, Inc.2004-10-07
K031203BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRISTDePuy Orthopaedics, Inc.2003-07-14
K030037UNIVERSAL TOTAL WRIST SYSTEMKinetikos Medical, Inc.2003-02-05
K021859WRIST IMPLANTAvanta Orthopaedics, Inc.2002-12-02
K020554MODIFICATION TO UNIVERSAL TOTAL WRIST SYSTEMKinetikos Medical, Inc.2002-05-03
K982156PASCO MIC AND MIC/ID PANELS/ CEFDINIRPasco Laboratories, Inc.1998-07-29
K961051UNIVERSAL TOTAL WRIST SYSTEM (MODIFICATION)Kinetikos Medical, Inc.1996-06-06
K931131THE RICHARDS WRISTSmith & Nephew Richards, Inc.1994-08-19
K802032MINI MICK APPLICATORMick Radio-Nuclear Instruments, Inc.1980-10-23