Identity
- Trade Name
- Arthrex® FDA UDI
- Generic Name
- Arthrodesis intramedullary nail, non-distracting FDA UDI
- Device Name
- Cortical screw, captured, 5.0 mm x 55 mm FDA UDI
- Model / Reference
- AR-9093-50-055 FDA UDI
- Description
- Cortical screw, captured, 5.0 mm x 55 mm FDA UDI
Identifiers
- Catalog Number
- AR-9093-50-055 FDA UDI
- Primary DI / UDI-DI
- 00888867410534 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Arthrodesis intramedullary nail, non-distracting FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3020 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
MR Conditional FDA UDI
Category: Arthrodesis intramedullary nail, non-distracting
Arthrex is a renowned orthopedic device brand that offers a range of innovative products for joint fusion and arthrodesis procedures. With its focus on precision, durability, and user-friendly design, Arthrex devices have become the gold standard in medical communities worldwide.
Similar devices
Also classified as Arthrodesis intramedullary nail, non-distracting.
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- INTREX — Bonetech Medisys Pvt. Ltd. · Class IIb
- Locking Screw — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- Ankle Compression Nailing System — Orthofix, Inc. · Class II
- Femoral Nail — WUHAN MINDRAY SCIENTIFIC CO., LTD. · Class IIb
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
- Arthrex, Inc.
Sources (1)
- FDA UDI 70a68228-e8d7-4fb8-9a8d-d2eca7b24c77 35 fields · synced Jul 19, 2026