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Proximal Aiming Device for Anteroposterior Interlocking, right
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Proximal Aiming Device for Anteroposterior Interlocking, right FDA UDI
- Generic Name
- Orthopaedic implant aiming arm FDA UDI
- Model / Reference
- 110300300 FDA UDI
Identifiers
- Catalog Number
- 110300300 FDA UDI
- Primary DI / UDI-DI
- 06902139111463 FDA UDI
- 510(k) Number
- K131609 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Orthopaedic implant aiming arm 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
No
FDA UDI
Implantable
No
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic implant aiming arm
Proximal Aiming Device for Anteroposterior Interlocking, right by Double Medical Technology Inc. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Orthopaedic implant aiming arm.
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- ANTEGRADE FEMORAL NAIL DRIVER — Biomet Orthopedics, Inc. · Class I
- Jig — I.T.S. GmbH · Class I
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- Proximal Humeral Fracture Plate System — Smith & Nephew, Inc. · Class I
Cleared under the same submission
K131609 also covers:
- 4.0mm Locking Screw — Double Medical Technology Inc.
- 4.0mm Locking Screw — Double Medical Technology Inc.
- 4.0mm 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.
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 f97ea7d0-77ce-4449-995d-6aa8ebb65608 35 fields · synced May 30, 2026