Avanta Orthopaedics Trapezial Implant

• • Terminated Z-0710-03 FDA Unclassified (pre-2012) ·initiated 24 Jan 2003

  Wrong silicone elastomer used in construction.

510(k) Number

K964381 ↗

FDA Product Code

KYI

Device Class

Class II

Regulation

21 CFR Part 888.3770

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• K'fix

  Class II

  FDA 510(k) K010847 Active Cleared 19 Jun 2001

• External Fixation

  Class II

  FDA 510(k) K981716 Active Cleared 17 Jul 1998

• Avanta Orthopaedics Trapezium Implant

  Class II

  FDA 510(k) K965204 Active Cleared 3 Jun 1997

• Avanta Orthopaedics Tendon Spacer

  Class II

  FDA 510(k) K964359 Active Cleared 25 Mar 1997

• Finger Joint Prosthesis

  Class II

  FDA 510(k) K013629 Active Cleared 25 Jan 2002

• Distal Radius Fracture Fixation Plate

  Class II

  FDA 510(k) K981715 Active Cleared 29 Jul 1998

See all devices from Avanta Orthopaedics, Inc. →