Identity
- Trade Name
- Integra® Freedom Wrist Arthroplasty System FDA UDI
- Generic Name
- Total wrist prosthesis FDA UDI
- Device Name
- The Integra Freedom Wrist Arthroplasty carpal implant is used in an assembly consisting of a titanium carpal plate, which is fixed into the carpal bones with a central peg and two titanium screws and locking caps. FDA UDI
- Model / Reference
- 348298E FDA UDI
- Description
- The Integra Freedom Wrist Arthroplasty carpal implant is used in an assembly consisting of a titanium carpal plate, which is fixed into the carpal bones with a central peg and two titanium screws and locking caps. FDA UDI
Identifiers
- Catalog Number
- 348298E FDA UDI
- Primary DI / UDI-DI
- 10381780066941 FDA UDI
- 510(k) Number
- K132250 FDA UDI
- FDA Product Code
- JWJ FDA UDI
- GMDN Term
- Total wrist prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Total wrist prosthesis
Integra® Freedom Wrist Arthroplasty System by Ascension Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total wrist prosthesis.
- Universal2 Total Wrist Implant System — Smith & Nephew, Inc. · Class II
- Freedom Wrist Arthroplasty System — Smith & Nephew, Inc. · Class II
- Universal2 Total Wrist Implant System — Smith & Nephew, Inc. · Class II
- KinematX — Extremity Medical, LLC · Class II
- Freedom Wrist Arthroplasty System — Smith & Nephew, Inc. · Class II
- Freedom Wrist Arthroplasty System — Smith & Nephew, Inc. · Class II
- Freedom Wrist Arthroplasty System — Smith & Nephew, Inc. · Class II
- KinematX — Extremity Medical, LLC · Class II
Cleared under the same submission
K132250 also covers:
- Integra® Freedom Wrist Arthroplasty System — Ascension Orthopedics, Inc.
- Integra® Freedom Wrist Arthroplasty System — Ascension Orthopedics, Inc.
- Integra® Freedom Wrist Arthroplasty System — Ascension Orthopedics, Inc.
- Integra® Freedom Wrist Arthroplasty System — Ascension Orthopedics, Inc.
- Integra® Freedom Wrist Arthroplasty System — Ascension Orthopedics, Inc.
- Integra® Freedom Wrist Arthroplasty System — Ascension Orthopedics, Inc.
- Integra® Freedom Wrist Arthroplasty System — Ascension Orthopedics, Inc.
- Integra® Freedom Wrist Arthroplasty System — Ascension Orthopedics, Inc.
- Integra® Freedom Wrist Arthroplasty System — Ascension Orthopedics, Inc.
- Integra® Freedom Wrist Arthroplasty System — Ascension Orthopedics, Inc.
- Integra® Freedom Wrist Arthroplasty System — Ascension Orthopedics, Inc.
- Integra® Freedom Wrist Arthroplasty System — Ascension Orthopedics, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ascension Orthopedics, Inc.
Sources (1)
- FDA UDI de907e6f-b77b-4556-a1cc-1844fe2d4581 39 fields · synced May 30, 2026