Identity
- Trade Name
- Insertion Handle for Tibial Nail FDA UDI
- Generic Name
- Orthopaedic implant aiming arm FDA UDI
- Model / Reference
- 110300100 FDA UDI
Identifiers
- Catalog Number
- 110300100 FDA UDI
- Primary DI / UDI-DI
- 06902139111449 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
Insertion Handle for Tibial Nail by Double Medical Technology Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic implant aiming arm.
- ANTEGRADE TARGETING MODULE FEMORAL NAIL SYSTEM — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class I
- TARGETING ARM — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class I
- Dyna Locking Trochanteric Nail — CG MedTech Co., Ltd. · Class I
- ANTEGRADE FEMORAL NAIL DRIVER — Biomet Orthopedics, Inc. · Class I
- Jig — I.T.S. GmbH · Class I
- ACUFEX — Smith & Nephew, Inc. · Class I
- ENDO - KNEE — Smith & Nephew, Inc. · Class I
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Double Medical Technology Inc.
Sources (1)
- FDA UDI 09aca8c8-d160-4293-ad30-33ca55771b48 35 fields · synced Jun 1, 2026