Identity
- Trade Name
- Arthrex® FDA UDI
- Generic Name
- Orthopaedic knee/leg holder liner FDA UDI
- Device Name
- TRIMANO Fortis Knee Kit FDA UDI
- Model / Reference
- AR-1747 FDA UDI
- Description
- TRIMANO Fortis Knee Kit FDA UDI
Identifiers
- Catalog Number
- AR-1747 FDA UDI
- Primary DI / UDI-DI
- 00888867279766 FDA UDI
- FDA Product Code
- BWN FDA UDI
- GMDN Term
- Orthopaedic knee/leg holder liner FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4950 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthopaedic knee/leg holder liner
Arthrex® by Arthrex, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic knee/leg holder liner.
- Knee Positioning Triangles™ — INNOVATIVE MEDICAL PRODUCTS, INC. · Class I
- De Mayo Universal Distractor® — INNOVATIVE MEDICAL PRODUCTS, INC. · Class I
- Thigh Holder Pad — Aspen Surgical Products, Inc. · Class I
- Knee Positioning Triangles™ — INNOVATIVE MEDICAL PRODUCTS, INC. · Class I
- De Mayo Universal Distractor® — INNOVATIVE MEDICAL PRODUCTS, INC. · Class I
- De Mayo Knee Positioner® — INNOVATIVE MEDICAL PRODUCTS, INC. · Class I
- FERKEL — Smith & Nephew, Inc. · Class I
- Alvarado® Knee Support — Zimmer Orthopaedic Surgical Products · 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 |
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Manufacturer
- Manufacturer
- Arthrex, Inc.
Sources (1)
- FDA UDI 721ee91e-d617-46c3-9013-90ef797537f2 35 fields · synced Jun 8, 2026