Orthosis, Spinal Pedicle Fixation
FDA product code MNI · 285 cleared devices
Class 2
Orthopedic
- Regulation
- 21 CFR 888.3070
- Review panel
- OR
- Implant
- Yes
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1998-03-20 – 2017-10-12
MNI
2008-07-02
MNI
2008-07-02
MYKRES SPINAL SYSTEM
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MNI
2008-05-21
CONQUEST SPINAL SYSTEM
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MNI
2008-05-12
CAPSURE PS (R) SPINE SYSTEM
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MNI
2008-04-09
PASS SPINAL SYSTEM
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MNI
2008-04-08
K2M COCR ROD
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MNI
2008-04-08
MODIFICATION TO:PILOT SPINAL SYSTEM
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MNI
2008-04-07
MODIFIED VERTIFLEX SPINAL SCREW SYSTEM
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MNI
2008-03-20
PSS SYSTEM
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MNI
2008-03-13
BLACKSTONE SFS PARALLEL ROD CONNECTORS
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MNI
2008-02-14
MODIFICATION TO STRYKER SPINE OASYS SYSTEM
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MNI
2008-01-28
MODIFICATION TO: VERTEFIX PEDICLE SCREW SPINAL SYSTEM
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MNI
2008-01-28
QUANTUM-MIS CANNULATED SYSTEM
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MNI
2008-01-10
SYNTHES OC FUSION AND SYNAPSE SYSTEMS
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MNI
2008-01-03
NATURAL BRIDGE LP TRANSVERSE CONNECTORS
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MNI
2007-11-01
MEGA SPINE SYSTEM
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MNI
2007-10-12
PIONEER LOWTOP SPINAL ROD SYSTEM
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MNI
2007-10-05
Optima ZS Transition Screw
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MNI
2007-09-21
MODIFICATION TO PASSMED SPINAL SYSTEM
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MNI
2007-09-17
LANX SPINAL FIXATION SYSTEM
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MNI
2007-09-04
ACME TALON PEDICLE SCREW
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MNI
2007-08-30
VERTEFIX PEDICLE SCREW SPINAL SYSTEM
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MNI
2007-08-21
PSS SYSTEM
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MNI
2007-08-08
DELTA SPINAL FUSION SYSTEM
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MNI
2007-08-06
NUVASIVE OCT SYSTEM
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MNI
2007-07-06
PILLAR PEDICLE SCREW SYSTEM
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MNI
2007-06-08
SYNAPSE SYSTEM
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MNI
2007-05-21
SINGLE PLANAR MULTI AXIAL (SPMA) PEDICLE SCREW SYSTEM
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MNI
2007-05-18
ROC LUMBAR SYSTEM
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MNI
2007-05-03
RANGE SPINAL SYSTEM
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MNI
2007-04-24
4S SPINAL SYSTEM
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MNI
2007-04-05
CAPSURE PEDICLE SCREW SYSTEM
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MNI
2007-02-05
SCIENT'X SPINAL SYSTEM
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MNI
2007-01-25
PILOT SPINAL SYSTEM
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MNI
2007-01-24
MODIFICATION TO EASYSPINE SYSTEM
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MNI
2006-12-22
TRAVERSE OCT SPINAL FIXATION SYSTEM
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MNI
2006-11-16
SIERRA
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MNI
2006-10-24
MODIFICATION TO STRYKER SPINE OASYS SYSTEM
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MNI
2006-10-11
TRIO + SPINAL SYSTEM
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MNI
2006-10-06
PASS 2 SPINAL SYSTEM
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MNI
2006-09-26
NEX-LINK SPINAL FIXATION SYSTEM OFFSET CONNECTORS, 2121-XX SERIES
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MNI
2006-09-25
CD HORIZON SPINAL SYSTEM
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MNI
2006-08-22
ARX SPINAL SYSTEM
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MNI
2006-08-11
EBI, L.P.'S LINE EXTENSION TO THE ARRAY SPINAL SYSTEM
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MNI
2006-08-10
EASYSPINE SYSTEM
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MNI
2006-07-03
MYKRES SPINAL SYSTEM
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MNI
2006-03-31
NEX-LINK SPINAL FIXATION SYSTEM ROD TO ROD CONNECTORS, MODELS 725, 726 SERIES
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MNI
2006-02-03
MODIFICATION TO S4 SPINAL SYSTEM
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MNI
2006-01-06
NEX-LINK SPINAL FIXATION SYSTEM OPEN POLYAXIAL SCREWS, MODELS 2112, 2113, 2118, 2119, 2120. NEX-LINK SPINAL FIXATION SY
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MNI
2006-01-05
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
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MNI
2005-12-12
CAPLESS PEDICLE SCREW SYSTEM
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MNI
2005-12-07
MESA SPINAL SYSTEM
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MNI
2005-12-06
XIA SPINAL SYSTEM
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MNI
2005-11-16
STRYKER SPINE TRIO SPINAL FIXATION SYSTEM
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MNI
2005-11-07
UNI-THREAD SPINAL SYSTEM
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MNI
2005-10-11
MODIFICATION TO: XIA 4.5 SPINAL SYSTEM
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MNI
2005-09-21
MODIFICATION TO: STRYKER SPINE OASYS SYSTEM
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MNI
2005-07-27
S4 SPINAL SYSTEM
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MNI
2005-05-23
POLYAXIAL HEMISPHERICAL SPINAL SCREWS
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MNI
2005-05-17
CD HORIZON SPINAL SYSTEM
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MNI
2005-05-16
LANX SPINAL FIXATION SYSTEM
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MNI
2005-05-04
LAGUNA PEDICLE SCREW SYSTEM
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MNI
2005-04-11
EXPEDIUM SPINE SYSTEM SPINOUS PROCESS FUSION PLATE
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MNI
2005-02-11
EASYSPINE SYSTEM
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MNI
2004-11-04
MSD SILO SPINAL SYSTEM
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MNI
2004-10-07
MODIFICATION TO BLACKSTONE MODULAR PEDICLE SCREW SYSTEM
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MNI
2004-10-07
MODIFICATION TO EQUATION FIXATION SYSTEM
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MNI
2004-09-20
BLACKSTONE ASCENT POCT SYSTEM 5.5MM/3.0MM SINGLE AXIAL CONNECTOR
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MNI
2004-09-03
MODIFICATION TO CD HORIZON SPINAL SYSTEM
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MNI
2004-09-03
OUTOLOGOUS SPINAL FIXATION SYSTEM
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MNI
2004-07-01
ORTHOPEDIC ALLIANCE SPINE SYSTEM
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MNI
2004-06-30
MODIFICATION TO CD HORIZON SPINAL SYSTEM
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MNI
2004-06-02
SUMMIT OCT SPINAL SYSTEM
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MNI
2004-05-28
MODIFICATION TO CD HORIZON SPINAL SYSTEM
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MNI
2004-03-31
MODIFICATION TO: CD HORIZON SPINAL SYSTEM
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MNI
2004-03-12
MODIFICATION TO ORIA TOP CLIP SYSTEM
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MNI
2004-03-04
SHIRAZ POSTERIOR SYSTEM
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MNI
2004-03-01
ART POSTERIOR SPINAL SYSTEM
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MNI
2004-02-25
VERTEBRON PSS PEDICLE SCREW SYSTEM
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MNI
2004-02-20
STRYKER SPINE OASYS SYSTEM
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MNI
2004-02-11
BLACKSTONE ASCENT POCT SYSTEM LATERAL OFFSET ADAPTER
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MNI
2004-01-27
SHIRAZ-JAVA SPINAL FIXATION SYSTEM
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MNI
2004-01-27
PLUS PIVOT LINK UNIVERSAL SYSTEM
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MNI
2004-01-22
POSTERIOR CABLE SCREW
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MNI
2003-12-19
REVOLUTION SPINAL FIXATION SYSTEM
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MNI
2003-12-03
MODIFICATION TO EQUATION FIXATION SYSTEM
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MNI
2003-11-20
UCR SPINAL SYSTEM
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MNI
2003-11-20
ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORS
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MNI
2003-11-06
DYNALOK CLASSIC SPINAL SYSTEM
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MNI
2003-10-31
PLUS PIVOT LINK UNIVERSAL SYSTEM
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MNI
2003-10-22
CONKLUSION PEDICLE SCREW SYSTEM
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MNI
2003-09-17
TSRH SPINAL SYSTEM
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MNI
2003-09-17
TSRH SPINAL SYSTEM
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MNI
2003-09-11
SPINAL CONCEPTS INC. NEX-LINK SPINAL FIXATION SYSTEM
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MNI
2003-09-04
CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE)
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MNI
2003-09-03
MODIFICATION TO CD HORIZON SPINAL SYSTEM
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MNI
2003-08-29
MODIFICATION TO UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM
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MNI
2003-08-06
EBI OMEGA21 SPINAL FIXATION SYSTEM
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MNI
2003-07-30
UCR SPINAL SYSTEM, LAMINAR HOOKS, PEDICLE HOOKS, AND INSTRUMENTS
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MNI
2003-06-27
MODIFICATION TO CD HORIZON SPINAL SYSTEM
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