Identity
- Trade Name
- Arthrex® FDA UDI
- Generic Name
- Orthopaedic graft tensioner, reusable FDA UDI
- Device Name
- TensionLoc Adjustable Tensioner FDA UDI
- Model / Reference
- AR-5202 FDA UDI
- Description
- TensionLoc Adjustable Tensioner FDA UDI
Identifiers
- Catalog Number
- AR-5202 FDA UDI
- Primary DI / UDI-DI
- 00888867342002 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic graft tensioner, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic graft tensioner, reusable
Arthrex® by Arthrex, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic graft tensioner, reusable.
- BIOSURE — Smith & Nephew, Inc. · Class I
- CONMED — Conmed Corporation · Class I
- Table Tensioner — Biomet Orthopedics, Inc. · Class I
- TABLE TENSIONER — Biomet Orthopedics, Inc. · Class I
- X-Wing Sliding Base — ENZTEC LIMITED · Class I
- BIOSURE — Smith & Nephew, Inc. · Class I
- ACL GRAFT TENSIONER — Biomet Orthopedics, Inc. · Class I
- X-Wing Tensioner — ENZTEC LIMITED · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Arthrex, Inc.
Sources (1)
- FDA UDI e6ae26ae-f584-4e36-a0a3-ce5838ccbc0c 35 fields · synced May 30, 2026