Medical Device Manufacturer · US , San Diego , CA

Avanta Orthopaedics, Inc. - FDA 510(k) Cleared Devices

18 submissions · 17 cleared · Since 1997

Recent clearances: AVANTA CARPAL FUSION PLATING SYSTEM, WRIST IMPLANT, MODIFICATION TO RADIAL HEAD IMPLANT

18

Total

17

Cleared

0

Denied

FDA 510(k) Regulatory Record - Avanta Orthopaedics, Inc. Orthopedic ✕

18 devices

1-12 of 18

Cleared Apr 10, 2003

AVANTA CARPAL FUSION PLATING SYSTEM

Orthopedic · 21d

Cleared Dec 02, 2002

Orthopedic · 179d

Cleared Nov 27, 2002

MODIFICATION TO RADIAL HEAD IMPLANT

Orthopedic · 30d

Cleared Jan 25, 2002

FINGER JOINT PROSTHESIS

Orthopedic · 81d

Cleared Jun 19, 2001

Orthopedic · 90d

Cleared Jun 19, 2001

RADIAL HEAD IMPLANT

Orthopedic · 8d

Cleared May 30, 2001

SCAPHIX, STAPLE, FIXATION, BONE

Orthopedic · 244d

Cleared Apr 11, 2001

ULNAR HEAD IMPLANT

Orthopedic · 27d

Cleared Nov 20, 2000

RADIAL HEAD IMPLANT

Orthopedic · 88d

Cleared Apr 29, 1999

DISTAL RADIUS FRACTURE FIXATION PLATE SYSTEM

Orthopedic · 64d

Cleared Dec 04, 1998

ULNAR HEAD IMPLANT

Orthopedic · 158d

Cleared Sep 08, 1998

RADIAL HEAD IMPLANT

Orthopedic · 70d