Medical Device Manufacturer · US , Effingham , IL

Bonutti Research, Inc. - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 1999
12
Total
12
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bonutti Research, Inc. Orthopedic ✕
10 devices
1-10 of 10
Cleared Jun 23, 2010
UNITY ULTRASONIC SYSTEM WITH PLLA ANCHORS
K093078 · HWC
Orthopedic · 266d
Cleared Sep 10, 2009
UNITY BETA PLLA SYSTEM
K090175 · HWC
Orthopedic · 230d
Cleared Oct 30, 2008
UNITY BETA ANCHOR SYSTEM
K082906 · HWC
Orthopedic · 30d
Cleared Mar 15, 2007
UNITY ALPHA SYSTEM
K062820 · HWC
Orthopedic · 176d
Cleared Feb 22, 2006
TRANSET SYSTEM
K060283 · HTY
Orthopedic · 19d
Cleared Dec 16, 2005
MULTITAK 6.0 MM ABSORBABLE ANCHOR SYSTEM
K052799 · MAI
Orthopedic · 74d
Cleared Feb 25, 2004
TRANSET FRACTURE FIXATION SYSTEM
K033717 · HTY
Orthopedic · 91d
Cleared Oct 29, 2001
MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR
K012465 · MAI
Orthopedic · 89d
Cleared May 08, 2001
MULTITAK CONICAL TIP BONE SOFT TISSUE SUTURE ANCHOR
K010479 · HTY
Orthopedic · 77d
Cleared Dec 17, 1999
MULTITAK SS
K993115 · MAI
Orthopedic · 88d
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All12 Orthopedic 10 General & Plastic Surgery 1 Physical Medicine 1