Identity
- Trade Name
- Arthrex® FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- SCRW, CORTICAL, 2.3 MM X 12 MM, SS, STRL FDA UDI
- Model / Reference
- AR-13123-12S FDA UDI
- Description
- SCRW, CORTICAL, 2.3 MM X 12 MM, SS, STRL FDA UDI
Identifiers
- Catalog Number
- AR-13123-12S FDA UDI
- Primary DI / UDI-DI
- 00888867286986 FDA UDI
- FDA Product Code
- JDR FDA UDI
- GMDN Term
- Orthopaedic bone screw (non-sliding) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 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: Orthopaedic bone screw (non-sliding)
Arthrex® by Arthrex, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone screw (non-sliding).
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- PANGEA — Stryker Corp. · Class II
- ARIX System Bone Screw — Jeil Medical Corporation · Class II
- Creed Ortholucent Implants — Glw, Inc. · Class II
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 9f4d94e9-fe04-476a-b6d7-a3e3255a98f7 35 fields · synced Jun 1, 2026