Identity
- Trade Name
- 4.0mm Locking Screw FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Model / Reference
- 071250060 FDA UDI
Identifiers
- Catalog Number
- 071250060 FDA UDI
- Primary DI / UDI-DI
- 06942782416638 FDA UDI
- 510(k) Number
- K131609 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 60 Millimeter FDA UDI
Category: Orthopaedic bone screw (non-sliding)
4.0mm Locking Screw by Double Medical Technology 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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- STARDRIVE — Synthes GmbH · Class IIb
- Arthrex® — Arthrex, Inc. · Class II
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- PANGEA — Stryker Corp. · Class II
Cleared under the same submission
K131609 also covers:
- 4.0mm Locking Screw — Double Medical Technology Inc.
- 4.0mm Locking Screw — Double Medical Technology Inc.
- 4.5mm Locking Screw for Tibial Nail — Double Medical Technology Inc.
- 4.5mm Locking Screw for Tibial Nail — Double Medical Technology Inc.
- 4.5mm Locking Screw for Tibial Nail — Double Medical Technology Inc.
- 4.9mm Locking Screw for DFN II/UFN II/UTN II — Double Medical Technology Inc.
- 4.9mm Locking Screw for DFN II/UFN II/UTN II — Double Medical Technology Inc.
- 4.9mm Locking Screw for DFN II/UFN II/UTN II — Double Medical Technology Inc.
- 4.9mm Locking Screw for DFN II/UFN II/UTN II — Double Medical Technology Inc.
- 5.0mm Dual Core Locking Screw — Double Medical Technology Inc.
- 5.0mm Dual Core Locking Screw — Double Medical Technology Inc.
- 5.0mm Dual Core Locking Screw — Double Medical Technology 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
- Double Medical Technology Inc.
Sources (1)
- FDA UDI f621d0f9-d004-4a72-b8d9-3b98308b6031 36 fields · synced Jun 8, 2026