Identity
- Trade Name
- ORTHOFIX FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- REVISION LOCKING SCREW L72.5MM D4.0MM STERILE FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- REVISION LOCKING SCREW L72.5MM D4.0MM STERILE FDA UDI
Identifiers
- Catalog Number
- 99-7240725 FDA UDI
- Primary DI / UDI-DI
- 18059015375015 FDA UDI
- 510(k) Number
- K233867 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Orthopaedic bone screw (non-sliding) 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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 4.0 Millimeter FDA UDILength — 72.5 Millimeter FDA UDI
Category: Orthopaedic bone screw (non-sliding)
Orthofix by Orthofix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone screw (non-sliding).
- EVOS — Smith & Nephew, Inc. · Class II
- TriLeap Lower Extremity Anatomic Plating System — CROSSROADS EXTREMITY SYSTEMS LLC · Class II
- Arthrex® — Arthrex, Inc. · Class II
- Zavation — ZAVATION · Class II
- STARDRIVE — Synthes GmbH · Class IIb
- Arthrex® — Arthrex, Inc. · Class II
- Cancellous Screw, Locking — I.T.S. GmbH · Class II
- PANGEA — Stryker Corp. · Class II
Cleared under the same submission
K233867 also covers:
- ORTHOFIX — Orthofix, Inc.
- ORTHOFIX — Orthofix, Inc.
- ORTHOFIX — Orthofix, Inc.
- ORTHOFIX — Orthofix, Inc.
- ORTHOFIX — Orthofix, Inc.
- ORTHOFIX — Orthofix, Inc.
- ORTHOFIX — Orthofix, Inc.
- ORTHOFIX — Orthofix, Inc.
- ORTHOFIX — Orthofix, Inc.
- ORTHOFIX — Orthofix, Inc.
- ORTHOFIX — Orthofix, Inc.
- ORTHOFIX — Orthofix, Inc.
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
- Orthofix, Inc.
Sources (1)
- FDA UDI f9b37aa6-a92e-47a4-90d0-9fb0ca8eeb01 37 fields · synced May 31, 2026