Identity
- Trade Name
- Arthrex® FDA UDI
- Generic Name
- Arthrodesis intramedullary nail, non-distracting FDA UDI
- Device Name
- HEADLESS CORTICAL SCREW, TI, 5.0x55MM FDA UDI
- Model / Reference
- AR-9050-55H FDA UDI
- Description
- HEADLESS CORTICAL SCREW, TI, 5.0x55MM FDA UDI
Identifiers
- Catalog Number
- AR-9050-55H FDA UDI
- Primary DI / UDI-DI
- 00888867317215 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
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Arthrodesis intramedullary nail, non-distracting
Arthrex® by Arthrex, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Arthrodesis intramedullary nail, non-distracting.
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- AUTOBAHN — GLOBUS MEDICAL, INC. · Class II
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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 ea370950-546c-4ced-a442-30c8bbfa1694 35 fields · synced May 30, 2026