Agile Nail
by Orthofix SRL
510(k) K172699
Agile Nail is a Class II device made by Orthofix SRL, cleared under FDA 510(k) K172699 on 23 Apr 2018, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK172699 | Date23 Apr 2018 | StatusActive |
Official records
- FDA 510(k) database K172699
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HSB
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3020
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent