Medical Device Manufacturer · US , Conway , NH

Custom Spine, Inc. - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 2005
12
Total
12
Cleared
0
Denied

Custom Spine, Inc. has 12 FDA 510(k) cleared orthopedic devices. Based in Conway, US.

Historical record: 12 cleared submissions from 2005 to 2015.

Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Custom Spine, Inc.
12 devices
1-12 of 12
Cleared Jul 22, 2015
PATHWAY ELIF
K143143 · MAX
Orthopedic · 261d
Cleared Apr 11, 2014
PROPOSED OPTIMUS
K132596 · OVD
Orthopedic · 235d
Cleared May 03, 2013
KOMPREDA
K120597 · MRW
Orthopedic · 430d
Cleared Feb 06, 2012
PATHWAY AVID
K111726 · MAX
Orthopedic · 231d
Cleared May 05, 2011
ISSYS LP SPINAL FIXATION SYSTEM
K111099 · NKB
Orthopedic · 15d
Cleared Dec 22, 2009
PATHWAY IVB/VBR
K092904 · ODP
Orthopedic · 92d
Cleared Aug 17, 2009
CUSTOM SPINE REGENT ANTERIOR CERVICAL PLATE
K091134 · KWQ
Orthopedic · 119d
Cleared Jun 01, 2009
PATHWAY AVID
K090566 · MAX
Orthopedic · 90d
Cleared May 01, 2008
PATHWAY
K080281 · MAX
Orthopedic · 87d
Cleared Dec 13, 2007
ISSYS LP SPINAL FIXATION SYSTEM
K072866 · KWP
Orthopedic · 69d
Cleared Jun 11, 2007
ISSYS LP SPINAL FIXATION SYSTEM
K070281 · NKB
Orthopedic · 133d
Cleared Jan 14, 2005
ISSYS PEDICLE SCREW SYSTEM
K043522 · KWP
Orthopedic · 25d
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