H-H Hunter Active Tendon Implant

No FDA recalls found in the data synced 10 Oct 2026.

510(k) Number

K853438 ↗

FDA Product Code

HXA

Device Class

Class II

Regulation

21 CFR Part 888.3025

Advisory Committee

Orthopedic

FDA Decision

SN

• H-H Alimentation Catheters

  Class II

  FDA 510(k) K821012 Active Cleared 28 May 1982

• H-H Fixation & Joining Connectors

  Class II

  FDA 510(k) K853369 Active Cleared 11 Sep 1985

• H-H Burr Hole Catheter Support

  Class II

  FDA 510(k) K820311 Active Cleared 24 Feb 1982

• H-H Hunter Active Tendon Implant Pc

  Class II

  FDA 510(k) K872284 Active Cleared 28 Sep 1987

• H-H Fixation and Joining Connectors

  Class II

  FDA 510(k) K790849 Active Cleared 11 May 1979

• Valve, H-H Cruciform Slit

  Class II

  FDA 510(k) K790126 Active Cleared 26 Jan 1979

See all devices from Holter-Hausner Intl. →