Agile Nail 1
Agile Nail 1 (183990C) is a Class II device made by Orthofix, Inc., cleared under FDA 510(k) K172699 on 23 Apr 2018 and listed in FDA GUDID since 8 May 2018 (UDI-DI 18054242519270), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number18054242519270 | Date8 May 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK172699 | Date23 Apr 2018 | StatusActive |
Official records
- AccessGUDID record 18054242519270
- FDA 510(k) database K172699
Across registries
- FDA 510(k) K172699 decided 23 Apr 2018 Active
- FDA GUDID UDI-DI 18054242519270 listed 8 May 2018 Listed
Timeline
- Cleared FDA 510(k) K172699
- Listed FDA GUDID 18054242519270
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Agile Nail
- Generic name
- General internal orthopaedic fixation system implantation kit
- Model / Ref / Catalog
- 1, 183990C
- Primary DI / UDI-DI
- 18054242519270
- 510(k) Number
- FDA product code
- HSB
- GMDN term
- General internal orthopaedic fixation system implantation kit
- Device class
- Class II
- Regulation number
- 888.3020
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
- Size
- Width — 27 Millimeter
Similar devices in this category
Other devices filed under General internal orthopaedic fixation system implantation kit.