Medical Device Manufacturer · US , Miami , FL

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

10 submissions · 10 cleared · Since 2000
10
Total
10
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hand Innovations, Inc. Orthopedic ✕
10 devices
1-10 of 10
Cleared Apr 26, 2005
DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM
K050932 · LXT
Orthopedic · 12d
Cleared Sep 30, 2004
SHOULDER FIXATION SYSTEM
K042059 · LXT
Orthopedic · 62d
Cleared Jul 30, 2004
MODIFICATION TO SMALL BONE FIXATION SYSTEM
K041157 · HTY
Orthopedic · 88d
Cleared Jul 01, 2004
FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES
K041081 · KTT
Orthopedic · 66d
Cleared Jan 15, 2004
SMALL BONE FIXATION SYSTEM
K033406 · HTY
Orthopedic · 83d
Cleared Oct 01, 2003
DISTAL RADIUS FRACTURE REPAIR SYSTEM
K032705 · LXT
Orthopedic · 29d
Cleared Apr 01, 2003
HAND INNOVATIONS, INC. DISTAL RADIUS FRACTURE REPAIR SYSTEM
K030198 · HRS
Orthopedic · 70d
Cleared Dec 05, 2002
DISTAL RADIUS FRACTURE REPAIR SYSTEM
K023007 · HRS
Orthopedic · 87d
Cleared Dec 20, 2001
INTRAMEDULLARY FIXATION SYSTEM FOR THE HAND
K013424 · HTY
Orthopedic · 66d
Cleared Dec 05, 2000
DISTAL VOLAR RADIUS FRACTURE REPAIR SYSTEM
K002775 · HRS
Orthopedic · 90d
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