Identity
- Trade Name
- AGILE NAIL FDA UDI
- Generic Name
- Orthopaedic implant aiming arm FDA UDI
- Device Name
- TARGETING HANDLE FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- TARGETING HANDLE FDA UDI
Identifiers
- Catalog Number
- 183100 FDA UDI
- Primary DI / UDI-DI
- 18054242518990 FDA UDI
- 510(k) Number
- K172699 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Width — 14 Millimeter FDA UDI
Category: Orthopaedic implant aiming arm
Agile Nail by Orthofix, 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
K172699 also covers:
- AGILE NAIL — Orthofix, Inc.
- AGILE NAIL — Orthofix, Inc.
- AGILE NAIL — Orthofix, Inc.
- AGILE NAIL — Orthofix, Inc.
- AGILE NAIL — Orthofix, Inc.
- AGILE NAIL — Orthofix, Inc.
- AGILE NAIL — Orthofix, Inc.
- AGILE NAIL — Orthofix, Inc.
- AGILE NAIL — Orthofix, Inc.
- AGILE NAIL — Orthofix, Inc.
- AGILE NAIL — Orthofix, Inc.
- AGILE NAIL — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Orthofix, Inc.
Sources (1)
- FDA UDI 64bcf528-fd5c-45dd-affe-c39896a949f1 37 fields · synced Jun 8, 2026