Medical Device Manufacturer · US , Minneapolis , MN

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

8 submissions · 7 cleared · Since 1995

Recent clearances: ORTHOPAEDIC INNOVATIONS RENEWAL ACETABULAR CUP SYSTEM, COBRA EXTERNAL FIXATOR, PRIME MODULAR ENDO HEAD

View 8 510(k) Devices ↓
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
K020145 · LPH
Orthopedic · 89d
Cleared Dec 04, 1998
COBRA EXTERNAL FIXATOR
K983881 · HRS
Orthopedic · 32d
Cleared Sep 23, 1996
PRIME MODULAR ENDO HEAD
K962646 · KWL
Orthopedic · 77d
Cleared Mar 18, 1996
PRACTIFIX EXTERNAL FIXATION SYSTEM
K960014 · KTT
Orthopedic · 76d
Cleared Feb 20, 1996
PRIME CEMENTED CALCAR FEMORAL STEMS
K955620 · JDI
Orthopedic · 71d
Cleared Jan 26, 1996
PRIME FEMORAL CEMENT PLUG
K955751 · LZN
Orthopedic · 37d
Cleared Sep 13, 1995
PRIME CEMENTED SMALL FEMORAL STEM
K953033 · JDI
Orthopedic · 75d
Cleared Apr 07, 1995
PRIME CEMENTED HIP SYSTEM
K940328 · JDI
Orthopedic · 438d
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