Appliance, Fixation, Spinal Interlaminal
FDA product code KWP · 408 cleared devices
Class 2
Orthopedic
- Regulation
- 21 CFR 888.3050
- Review panel
- OR
- Implant
- Yes
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1978-09-27 – 2013-12-11
KWP
2013-12-11
KWP
2013-11-25
TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM
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KWP
2013-10-25
MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEM
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KWP
2013-10-24
LOTUS
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KWP
2013-08-22
MOUNTAINEER OCT SPINAL SYSTEM
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KWP
2013-05-24
LANX SPINAL FIXATION SYSTEM
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KWP
2013-04-01
VERTEX RECONSTRUCTION SYSTEM, VERTEXT SELECT RECONSTRUCTION SYSTEM
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KWP
2013-03-21
PASS OCT SPINAL SYSTEM
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KWP
2013-03-14
ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM AND CAPITOL IMPLANTS
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KWP
2013-02-25
VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
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KWP
2013-02-12
GIBRALT OCCIPITAL PLATE SCREWS, SET SCREW, GIBRALT OCCIPITAL SYSTEM ARTICULATING ROD, GIBRALT OCCIPITAL PLATES
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KWP
2013-02-07
SPINEOLOGY SPINOUS PROCESS PLATE
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KWP
2012-12-20
STABILINK MIS SPINAL FIXATION SYSTEM
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KWP
2012-12-18
VERTEX RECONSTRUCTION SYSTEM
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KWP
2012-12-17
VERTIFLEX SPINOUS PROCESS FIXATION PLATE
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KWP
2012-11-07
PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) SYSTEM
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KWP
2012-10-24
RELIANCE POSTERIOR CERVICAL- THORACIC SYSTEM
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KWP
2012-10-01
SOLSTICE CROSS CONNECTOR
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KWP
2012-09-20
NEXTGEN ALTIUS OCT SYSTEM
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KWP
2012-08-09
RENOIR POSTERIOR CERVIAL FIXATION SYSTEM
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KWP
2012-07-20
CASIAN, 3.5/4.5 CONNECTORS
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KWP
2012-07-18
M.U.S.T PEDICLE SCREW SYSTEM
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KWP
2012-06-29
VERTEX RCCONSTRUCTION SYSTEM
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KWP
2012-04-17
NEXTGEN ALTIUS OCT SYSTEM
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KWP
2012-03-28
REXIOUS HOOK FIXATION SYSTEMS
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KWP
2012-03-12
PIONEER POSTERIOR CERVICO THORACIC SYSTEM
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KWP
2012-02-28
NEON SYSTEM
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KWP
2012-02-13
COFLEX-F
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KWP
2012-01-19
OASYS SPINAL SYSTEM
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KWP
2012-01-12
CASPIAN
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KWP
2011-12-05
AXLE PEEK INTERSPINOUS FUSION SYSTEM
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KWP
2011-09-15
SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM
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KWP
2011-06-02
BRIDGEPOINT SPINOUS PROCESS CAMP- POSTERIOR FIXATION SYSTEM
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KWP
2011-05-24
ASCENT POSTERIOR OCCIPITAL THORACIC (POCT) SYSTEM (TITANIUM & COBALT CHROME RODS)
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KWP
2011-05-05
ELLIPSE OCCIPITO-CERVICO-THORACIC SPINAL SYSTEM
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KWP
2011-04-15
LANX SPINAL FIXATION SYSTEM
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KWP
2011-04-07
MOUNTAINEER OCT SPINAL SYSTEM
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KWP
2011-04-01
VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
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KWP
2011-03-23
PIONEER SPINAL PROCESS FUSION PLATE
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KWP
2011-01-26
CD HORIZON SPINAL SYSTEM
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KWP
2011-01-19
SP-FIX SPINOUS PROCESS FIXATION PLATE
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KWP
2011-01-13
CASPIAN SPINAL SYSTEM
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KWP
2010-11-24
AXLE INTERSPINOUS FUSION SYSTEM
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KWP
2010-11-15
MODIFICATION TO LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM
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KWP
2010-11-09
MODIFICATION TO: OASYS SYSTEM
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KWP
2010-11-04
RELIANCE SPINAL SCREW SYSTEM
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KWP
2010-10-22
PIONEER SPINOUS PROCESS FUSION PLATE
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KWP
2010-10-06
PARADIGM INTERSPINOUS FUSION PLATE
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KWP
2010-10-04
CASPIAN SPINAL SYSTEM
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KWP
2010-09-01
VEGA SPAN SPINOUS PROCESS PLATE SYSTEM
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KWP
2010-08-17
PRIMAL OK INTERSPINOUS FUSION SYSTEM
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KWP
2010-06-23
NUVASIVE VUEPOINT OCT SYSTEM
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KWP
2010-06-18
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
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KWP
2010-04-15
LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)
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KWP
2010-03-16
APEX SPINE SYSTEM 5.50 MM TITANIUM ROD & POLYAXIAL SCREW WASHER
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KWP
2010-02-19
PIONEER POSTERIOR CERVICO-THORACIC SYSTEM
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KWP
2009-12-16
MODIFICATION TO CASPIAN SPINAL SYSTEM
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KWP
2009-11-24
LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM
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KWP
2009-09-02
GSO PCT SPINAL SYSTEM
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KWP
2009-08-11
SENTINEL SPINAL SYSTEM
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KWP
2009-08-06
VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
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KWP
2009-07-10
SYNAPSE SYSTEM 4.0MM, OC FUSION SYSTEM 4.0MM
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KWP
2009-06-30
ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM
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KWP
2009-06-02
NEXLINK OCT SYSTEM, MODEL 7000 SERIES
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KWP
2009-05-21
SYNTHES SYNAPSE TRANSCONNECTOR
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KWP
2009-04-17
VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
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KWP
2009-03-04
MODIFICATION TO: LANX SPINAL FIXATION SYSTEM
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KWP
2009-01-16
VERTEX RECONTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
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KWP
2008-12-11
MESA AND RANGE SPINAL SYSTEMS
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KWP
2008-11-14
VERTEX RECONSTRUCTION SYSTEM
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KWP
2008-11-14
PROTEX CT CERVICOTHORACIC SPINAL SYSTEM
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KWP
2008-10-10
CASPIAN SPINAL SYSTEM, SCREWS, RODS, HOOKS, ROD CONNECTORS
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KWP
2008-06-11
VERTEX RECONSTRUCTION SYSTEM
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KWP
2008-04-29
MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC SYSTEM
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KWP
2008-04-18
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
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KWP
2008-04-17
SIERRA
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KWP
2008-04-16
SIERRA SYSTEM
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KWP
2008-03-28
SPINOUS PROCESS PLATE SYSTEM
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KWP
2008-03-13
BLACKSTONE ASCENT POSTERIOR OCCIPITAL CERVICO-THORACIC (POCT) SYSTEM
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KWP
2008-02-14
BLACKSTONE ASCENT MULTIAXIAL SCREWS
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KWP
2008-01-24
BLACKSTONE ASCENT POCT SYSTEM PARALLEL ROD CONNECTOR
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KWP
2007-12-13
ISSYS LP SPINAL FIXATION SYSTEM
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KWP
2007-12-11
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
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KWP
2007-10-24
ZODIAC DYNAMO SEMI-RIGID SPINAL SYSTEM
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KWP
2007-10-15
TRAVERSE OCT SPINAL FIXATION SYSTEM
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KWP
2007-10-05
MODIFICATION TO OASYS SYSTEM
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KWP
2007-09-14
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
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KWP
2007-08-15
LANX DEFORMITY SYSTEM
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KWP
2007-08-08
LDR SPINE EASYSPINE POSTERIOR OSTEOSYNTHESIS SYSTEM
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KWP
2007-08-06
POLARIS BE RODS
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KWP
2007-07-20
GSO GS1 SPINAL SYSTEM
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KWP
2007-05-30
THEKEN ATOLL CERVICO-THORACIC SYSTEM
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KWP
2007-05-25
ANATOMICA POSTERIOR CERVICAL FIXATION SYSTEM
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KWP
2007-04-10
EXPEDIUM SFX CROSS CONNECTOR SYSTEM
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KWP
2007-01-16
C-JAWS CERVICAL COMPRESSIVE MINI FRAME
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KWP
2006-12-26
LTD POLYAXIAL FIXATION SYSTEM
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KWP
2006-12-22
APEX SPINE SYSTEM
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KWP
2006-09-08
MODIFICATION TO CD HORIZON SPINAL SYSTEM
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KWP
2006-09-06
SYNTHES OC FUSION SYSTEM
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KWP
2006-08-11
MODIFICATION TO CD HORIZON SPINAL SYSTEM
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