Medical Device Manufacturer · US , Minneapolis , MN

Orthopaedic Innovations, Inc. - FDA 510(k) Cleared Devices

8 submissions · 7 cleared · Since 1995

8

Total

7

Cleared

0

Denied

FDA 510(k) Regulatory Record - Orthopaedic Innovations, Inc. Orthopedic ✕

8 devices

1-8 of 8

Cleared Apr 15, 2002

ORTHOPAEDIC INNOVATIONS RENEWAL ACETABULAR CUP SYSTEM

Orthopedic · 89d

Cleared Dec 04, 1998

COBRA EXTERNAL FIXATOR

Orthopedic · 32d

Cleared Sep 23, 1996

PRIME MODULAR ENDO HEAD

Orthopedic · 77d

Cleared Mar 18, 1996

PRACTIFIX EXTERNAL FIXATION SYSTEM

Orthopedic · 76d

Cleared Feb 20, 1996

PRIME CEMENTED CALCAR FEMORAL STEMS

Orthopedic · 71d

Cleared Jan 26, 1996

PRIME FEMORAL CEMENT PLUG

Orthopedic · 37d

Cleared Sep 13, 1995

PRIME CEMENTED SMALL FEMORAL STEM

Orthopedic · 75d

Cleared Apr 07, 1995

PRIME CEMENTED HIP SYSTEM

Orthopedic · 438d