Medical Device Manufacturer · US , Broomfield , CO

Lanx, Inc. - FDA 510(k) Cleared Devices

23 submissions · 23 cleared · Since 2009
23
Total
23
Cleared
0
Denied
FDA 510(k) Regulatory Record - Lanx, Inc. Orthopedic
23 devices
1-23 of 23
Cleared Jul 12, 2013
LANX FUSION SYSTEM
K131547 · OVD
Orthopedic · 44d
Cleared May 24, 2013
LANX SPINAL FIXATION SYSTEM
K131156 · KWP
Orthopedic · 30d
Cleared Mar 18, 2013
LANX FUSION SYSTEM- SA
K123767 · OVD
Orthopedic · 101d
Cleared Sep 10, 2012
LANX SPINAL FIZATION SYSTEM
K121316 · NKB
Orthopedic · 131d
Cleared Aug 17, 2012
LANX SPINAL FIXATION SYSTEM
K122145 · NKB
Orthopedic · 29d
Cleared Aug 02, 2012
LANX SPINAL FIXATION SYSTEM
K121940 · NKB
Orthopedic · 31d
Cleared Dec 19, 2011
LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)
K113434 · NKB
Orthopedic · 28d
Cleared Dec 16, 2011
LANX CERVICAL SA
K112388 · OVE
Orthopedic · 120d
Cleared Apr 15, 2011
LANX SPINAL FIXATION SYSTEM
K103091 · KWP
Orthopedic · 178d
Cleared Mar 25, 2011
LANX SPINAL SYSTEM
K103237 · NKB
Orthopedic · 143d
Cleared Mar 23, 2011
LANX LATERAL
K103666 · MAX
Orthopedic · 98d
Cleared Feb 28, 2011
LANX CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
K103660 · ODP
Orthopedic · 75d
Cleared Nov 15, 2010
MODIFICATION TO LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM
K100888 · KWP
Orthopedic · 230d
Cleared Aug 16, 2010
LANX FACET SCREW SYSTEM
K101364 · MRW
Orthopedic · 94d
Cleared Aug 06, 2010
LANX SPINAL FIXATION SYSTEM
K100935 · NKB
Orthopedic · 123d
Cleared Apr 15, 2010
LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)
K100191 · KWP
Orthopedic · 83d
Cleared Apr 07, 2010
LANX ANTERIOR PLATING SYSTEM
K092765 · KWQ
Orthopedic · 210d
Cleared Nov 24, 2009
LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM
K092656 · KWP
Orthopedic · 88d
Cleared Oct 30, 2009
SPINAL FIXATION SYSTEM
K092536 · NKB
Orthopedic · 72d
Cleared Apr 20, 2009
LANX FUSION SYSTEM
K083815 · MAX
Orthopedic · 119d
Cleared Apr 07, 2009
LANX SPINAL FIXATION SYSTEM
K083581 · MNH
Orthopedic · 124d
Cleared Apr 07, 2009
MODIFICATION TO: LANX ANTERIOR CERVICAL PLATE SYSTEM
K090316 · KWQ
Orthopedic · 57d
Cleared Mar 04, 2009
MODIFICATION TO: LANX SPINAL FIXATION SYSTEM
K090252 · KWP
Orthopedic · 30d
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