FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Freedom Wrist Arthroplasty System
K Number: K233674
·
Decision May 30, 2024
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
16
Applicant Total
22
Review Days
196
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Basic Information
- Device Name
- Freedom Wrist Arthroplasty System
- K Number
- K233674
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3800
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ascension Orthopedics, Inc.
- Date Received
- November 16, 2023
- Decision Date
- May 30, 2024
- Product Code
- JWJ
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JWJ | Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JWJ), ordered by most recent decision date.
Total Wrist Arthroplasty System (TWA)
FDA 510(k)
FDA Class 2
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Total Wrist Arthroplasty System (TWA)
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FDA Class 2
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Arthrosurface WristMotion Total Wrist Arthroplasty System
FDA 510(k)
FDA Class 2
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KinematX Total Wrist Arthroplasty System
FDA 510(k)
FDA Class 2
·Orthopedic
INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MAESTRO WRIST FRACTURE IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Ascension Orthopedics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K233670 | Ascension Silicone MCP; Ascension Silicone PIP | Dec 14, 2023 | Substantially Equivalent |
| K121826 | INTEGRA PROXIMAL HUMERAL PLATE SYSTEM | Feb 13, 2013 | Substantially Equivalent |
| K110700 | ASCENSION ATLAS HUMERAL PLATING SYSTEM | Dec 6, 2011 | Substantially Equivalent |
| K102549 | THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY | Dec 21, 2010 | Substantially Equivalent |
| K100448 | ASCENSION MODULAR TOTAL SHOULDER SYSTEM | Aug 30, 2010 | Substantially Equivalent |
| K100502 | ASCENSION TOTAL PLATE SYSTEM | Aug 2, 2010 | Substantially Equivalent |
| K100925 | ASCENSION ANKLE FUSION NAIL SYSTEM | Jul 12, 2010 | Substantially Equivalent |
| K100176 | ASCENSION ANKLE FUSION PLATE SYSTEM | Jun 16, 2010 | Substantially Equivalent |
| K092047 | ASCENSION METAL GREAT TOE SYSTEM | Jan 14, 2010 | Substantially Equivalent |
| K092440 | ASCENSION CANNULATED SCREW SYSTEM | Nov 5, 2009 | Substantially Equivalent |