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
2006-05-23
KWP
2006-04-18
ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM
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KWP
2006-03-10
SINTEA BIOTECH PLS MULTI-AXIAL SCREWS, MODEL PLS.XX.T5.X
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KWP
2006-02-13
BASIS SPINAL SYSTEM
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KWP
2005-11-10
SOLANAS POSTERIOR STABILIZATION SYSTEM
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KWP
2005-10-21
MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM
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KWP
2005-09-28
EXPEDIUM SPINE SYSTEM 5.5MM COMMERICALLY PURE TITANIUM SPINAL RODS
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KWP
2005-09-23
VERTEX RECONSTRUCTION SYSTEM
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KWP
2005-09-23
MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM
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KWP
2005-09-23
SYNTHES PANGEA SYSTEM
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KWP
2005-09-14
NEX-LINK SPINAL FIXATION SYSTEM VARIABLE CROSSLINK, MODEL 721-XX
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KWP
2005-09-08
MODIFICATION TO XIA SPINAL SYSTEM
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KWP
2005-09-07
VERTEBRON PSS PEDICLE SCREW SYSTEM
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KWP
2005-08-23
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
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KWP
2005-08-18
MODIFICATION TO: XIA STAINLESS STEEL SYSTEM
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KWP
2005-08-17
PROTEX STABILIZATION SYSTEM WITH ADDITIONAL COMPONENTES
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KWP
2005-07-27
MALIBU SPINAL SYSTEM
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KWP
2005-07-21
PROTEX CT CERVICOTHORACIC SPINAL SYSTEM
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KWP
2005-06-22
ZODIAC SPINAL FIXATION SYSTEM
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KWP
2005-06-14
CD HORIZON SPINAL SYSTEM
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KWP
2005-05-04
BASIS SPINAL SYSTEM
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KWP
2005-04-11
MODIFICATION TO CD HORIZON SPINAL SYSTEM
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KWP
2005-02-16
TECHTONIX SYSTEM
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KWP
2005-02-10
CD HORIZON SPINAL SYSTEM
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KWP
2005-01-14
ISSYS PEDICLE SCREW SYSTEM
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KWP
2005-01-12
MODIFICATION TO XIA SPINAL SYSTEM
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KWP
2005-01-10
DENALI SPINE SYSTEM
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KWP
2005-01-07
GLAXY 3.2 SPINAL SYSTEM
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KWP
2004-12-21
MODIFICATION TO ALTIUS OCT SYSTEM
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KWP
2004-12-21
VERTEX RECONSTRUCTION SYSTEM
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KWP
2004-12-17
SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RECOVERY SCREWS, MODEL PLS.01.T5.X
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KWP
2004-10-27
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
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KWP
2004-10-08
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
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KWP
2004-10-07
SUMIT OCT SPINAL SYSTEM AND MOUNTAINEER OCT SPINAL SYSTEM
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KWP
2004-10-07
VERTEX RECONSTRUCTION SYSTEM
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KWP
2004-10-07
EXCELLA-M SPINAL SYSTEM
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KWP
2004-10-01
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
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KWP
2004-10-01
ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM
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KWP
2004-09-24
ST360 SPINAL FIXATION SYSTEM
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KWP
2004-09-16
CORAL SPINAL SYSTEM
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KWP
2004-09-15
CD HORIZON SPINAL SYSTEM
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KWP
2004-07-19
EXPEDIUM SPINE SYSTEM
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KWP
2004-07-01
SYNERGY HELICAL FLANGE PLUG, HELICAL FLANGE SEAT AND HELICAL FLANGE REDUCTION SEAT
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KWP
2004-07-01
SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEM
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KWP
2004-06-10
MODIFICATION TO TSRH SPINAL SYSTEM
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KWP
2004-04-14
ALTIUS OCT SYSTEM
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KWP
2004-03-26
ICON POLYAXIAL PEDICLE SCREW SYSTEM
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KWP
2004-03-03
BLACKSTONE ASCENT POCT SYSTEM HOOKS (SYSTEM MODIFICATION)
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KWP
2003-11-14
PASSMED SPINAL SYSTEM
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KWP
2003-11-14
CLICK'X MONOAXIAL SCREWS AND HOOKS
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KWP
2003-10-10
ORIA SPINAL CLIP SYSTEM, LATERAL INTERMEDIATE CONNECTOR, MODEL AL01
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KWP
2003-09-05
TI FENESTRATED PLATE
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KWP
2003-08-20
MODIFICATION ORIA SPINAL SYSTEM
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KWP
2003-07-17
XIA SPINAL SYSTEM AND XIA STAINLESS STEEL SYSTEM
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KWP
2003-06-24
U & I AMERICA SPINAL HOOK SYSTEM
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KWP
2003-06-24
MODIFICATION TO COLORADO 2 SPINAL SYSTEM
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KWP
2003-06-18
ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03
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KWP
2003-06-13
VANTAGE ANTERIOR FIXATION SYSTEM
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KWP
2003-06-12
BLACKSTONE POSTERIOR CERVICAL SYSTEM
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KWP
2003-06-06
MSD CABLE REDUCTION SYSTEM
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KWP
2003-04-24
MODIFICATION TO XIA STAINLESS STEEL SYSTEM
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KWP
2003-02-21
ORIA SPINAL CLIP SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06
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KWP
2003-02-21
ORIA SPINAL CLIP SYSTEM EXTENDED OMNIAXIAL CONNECTORS (CO05 & CO07)
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KWP
2003-02-21
MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM
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KWP
2003-01-23
MOSS MIAMI SPINAL SYSTEM PIN NUT
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KWP
2002-12-13
LAURAIN DEWALD ANTERIOR FIXATION SYSTEM
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KWP
2002-12-13
MODIFICATION TO DYNALOK CLASSIC SPINAL SYSTEM
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KWP
2002-12-10
CD HORIZON SPINAL SYSTEM
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KWP
2002-12-04
INTERPORE CROSS INTERNATIONAL (ICI) OCCIPITO-CERVICO-THORACIC (OCT) ROD AND PLATE SYSTEM
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KWP
2002-11-26
SYNTHES CERVIFIX/ AXON
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KWP
2002-11-22
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
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KWP
2002-11-19
ORIA SPINAL CLIP SYSTEM
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KWP
2002-11-13
MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM
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KWP
2002-09-24
CADENCE SPINAL FIXATION SYSTEM
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KWP
2002-08-28
MODIFICATION TO TENOR SPINAL SYSTEM
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KWP
2002-08-27
5.0 MM DIAMETER POLYAXIAL SCREWS (MOSS MIAMI 6.35MM SYSTEM)
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KWP
2002-08-01
PLUS PIVOT LINK UNIVERSAL SYSTEM
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KWP
2002-07-25
MODIFICATION TO CD HORIZON SPINAL SYSTEM
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KWP
2002-07-22
XANTUS ANTERIOR LATERAL SUPPLEMENTAL FIXATION SYSTEM
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KWP
2002-07-18
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
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KWP
2002-07-09
TSRH SPINAL SYSTEM
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KWP
2002-07-03
SCS CLARIS SPINAL SYSTEM,REXTENDED OMNIAXIAL CONNECTOR-,MEDIUM, MODEL CO05, SCS CLARIS SPINAL SYSTEM,EXTENDED OMNIAXIALO
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KWP
2002-07-01
MODIFICATION TO SPIRAL RADIUS 90-D SST SYSTEM
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KWP
2002-06-18
OCTAFIX OCCIPITAL CERVICAL PLATING SYSTEM
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KWP
2002-05-09
MODIFICATION TO CD HORIZON SPINAL SYSTEM
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KWP
2002-04-15
SPIRAL RADIUS 90-D RODDING SYSTEM
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KWP
2002-03-11
ENDIUS SPINAL FIXATION SYSTEM
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KWP
2002-02-26
MSD WIRE SYSTEM
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KWP
2002-02-14
MODIFICATION TO PASS SPINAL SYSTEM
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KWP
2002-02-13
P.L.U.S. SYSTEM (PIVOT LINK UNIVERSAL SYSTEM)
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KWP
2002-02-05
DYNA-LOK CLASSIC SPINAL SYSTEM
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KWP
2002-01-30
ASCEND SPINAL FIXATION SYSTEM WITH THE SHADOW SPINAL SYSTEM
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KWP
2002-01-25
BUTTERFLY PLATE FIXATION SYSTEM
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KWP
2002-01-15
ISOBAR SPINAL SYSTEM
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KWP
2002-01-15
PASS SPINAL SYSTEM
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KWP
2001-12-19
XIA SPINAL SYSTEM
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KWP
2001-11-27
EBI SPINELINK - II SPINAL FIXATION SYSTEM
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KWP
2001-11-16
ISOLA POLYAXIAL WASHER
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KWP
2001-09-28
DEVICE MODIFICATION OF SILHOUETTE SPINDAL FIXATION SYSTEM
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KWP
2001-09-28
VERTEX RECONSTRUCTION SYSTEM
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