GAMMA3 Nail System

by Howmedica Osteonics Corp. 2 variants

510(k) K043431

GAMMA3 Nail System is a Class II device made by Howmedica Osteonics Corp., cleared under FDA 510(k) K043431 on 16 Feb 2005, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K043431↗

FDA record

Trust

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK043431	Date16 Feb 2005Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K043431

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K043431
FDA product code: HSB

Device class: Class II
Regulation: 21 CFR Part 888.3020
Advisory committee: Orthopedic
FDA decision: SESE Substantially Equivalent

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