Thoracolumbosacral Pedicle Screw System
FDA product code NKB · 809 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
- 2003-02-25 – 2026-09-27
Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.
NKB
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NKB
2012-10-01
TANGORS MULTIFUNCTIONAL POSTERIOR SYSTEM
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XIA 3 SPINAL SYSTEM
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NUVASIVE POLYAXIAL SPINAL SCREWS
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2012-08-24
LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EASYSPINE, POSTERIOR SPINAL SYSTEM, LDR SPINE USA MC IMPLANT S
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2012-08-21
CD HORIZON SPINAL SYSTEM
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NKB
2012-08-17
LANX SPINAL FIXATION SYSTEM
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NKB
2012-08-13
ERISMA-LP
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2012-08-09
PICASSO MIS SPINAL FIXATION SYSTEM
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2012-08-07
NAUTILUS SPINAL SYSTEM
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2012-08-02
LANX SPINAL FIXATION SYSTEM
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2012-07-31
SYNTHES MATRIX SYSTEM
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2012-07-30
STERISPINEPS PEDICLE SCREW, STERISPINEPS ROD
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NKB
2012-07-30
SPINAL ELEMENTS POSTERIOR CERVICAL/THORACIC SPINAL SYSTEM
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NKB
2012-07-26
BEACON STABILIZATION SYSTEM
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NKB
2012-07-18
PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM
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NKB
2012-07-16
CALYPSO SYSTEM
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NKB
2012-07-05
CD HORIZON SPINAL SYSTEM
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NKB
2012-06-22
XIA 4.5 SPINAL SYSTEM
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NKB
2012-06-15
POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODS
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NKB
2012-06-14
REVERE 4.5 STABILIZATION SYSTEM
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NKB
2012-06-14
EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM
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NKB
2012-06-07
SPINEVISION LUMIS(TM) CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S.(TM) POLYAXIAL PEDICLE ...
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NKB
2012-05-30
STAINLESS STEEL SPINAL SYSTEM
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NKB
2012-05-18
SYNTHES MATRIX SYSTEM
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NKB
2012-05-18
R&D INNOVATION PEDICLE SCREW SYSTEM
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NKB
2012-05-14
SYNTHES USS CONNECTOR
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NKB
2012-05-03
VIPER SYSTEM
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NKB
2012-05-01
MONT BLANC PEDICLE SCREW SYSTEMS
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NKB
2012-04-03
SECURIS SPINAL FIXATION
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NKB
2012-03-29
TIGER SPINE SYSTEM
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NKB
2012-03-26
VENUS SPINAL FIXATION SYSTEM
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NKB
2012-03-14
FOUNDATION SPINAL SYSTEM
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NKB
2012-03-09
LANX SPINAL FIXATION SYSTEM
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NKB
2012-03-08
POWER ADAPTOR INSTRUMENT ACCESSORY
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NKB
2012-03-07
LEUCADIA 4.5 MM PEDICLE SCREW SYSTEM
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NKB
2012-02-16
ICON (TM) MODULAR PEDICLE SCREW SYSTEM
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NKB
2012-02-15
FOCUS SPINAL SYSTEM
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NKB
2012-02-09
CD HORIZON VOYAGER SPINAL SYSTEM
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NKB
2012-02-08
DEPUY PULSE THORACOLUMBAR SCREW SYSTEM
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NKB
2012-02-03
CORAL SPINAL SYSTEM
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NKB
2012-01-25
XENON(TM) PEDICLE SCREW SYSTEM
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NKB
2012-01-19
NANOVIS SPINAL SYSTEM
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NKB
2012-01-17
LEUCADIA AUTOLOK PEDICLE SCREW SYSTEM
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NKB
2012-01-10
DSS STABILIZATION SYSTEM
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NKB
2012-01-04
FOCUS MIS SYSTEM
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NKB
2011-12-21
SYNTHES MIRS
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NKB
2011-12-19
LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)
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NKB
2011-12-16
INSTINCT JAVA SYSTEM
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NKB
2011-12-07
ATHENA PEDICLE SCREW SYSTEM
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NKB
2011-11-21
CD HORIZON SPINAL SYSTEM
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NKB
2011-11-21
S4 SPINAL SYSTEM
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NKB
2011-11-18
SYNTHES USS
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NKB
2011-11-15
STERISPINEPS PEDICLE SCREW
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NKB
2011-11-02
LEUCADIA(TM) MIS PEDICLE SCREW SYSTEM
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NKB
2011-10-27
MAHE PERFECT SPINE- PEDICLE SCREW SYSTEM
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NKB
2011-10-26
EXPEDIUM SPINE SYSTEM
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NKB
2011-10-21
CD HORIZON SPINAL SYSTEM
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NKB
2011-10-18
APCLO PEDICLE SCREW SYSTEMS
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NKB
2011-09-27
CD HORIZON(R) SPINAL SYSTEM
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NKB
2011-09-15
CD HORIZON SPINAL SYSTEM
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NKB
2011-09-15
CD HORIZON SPINAL SYSTEM
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NKB
2011-09-07
PILOT SPINAL SYSTEM
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NKB
2011-08-30
TSRH SPINAL SYSTEMS
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NKB
2011-08-26
INSTINCT JAVA SYSTEM
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NKB
2011-08-23
STREAMLINE TL SPINAL SYSTEM
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NKB
2011-08-19
POLARIS SPINAL SYSTEM
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NKB
2011-08-17
REVERE CROSSTOP
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NKB
2011-08-17
REVOLVE ADDITIONAL IMPLANTS
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NKB
2011-08-04
STRYKER SPINE POWER ADAPTOR (ACCESSORY INSTRUMENT)
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NKB
2011-08-02
DEL MAR MONOAXIAL PEDICLE SCREW SYSTEM
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NKB
2011-07-26
APEX SPINE SYSTEM
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NKB
2011-07-21
GENESYS SPINE TILOCK SYSTEM
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NKB
2011-07-13
ATLAS SPINE PEDICLE SCREW SYSTEM
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NKB
2011-07-12
SOLANAS AVALON POSTERIOR FIXATION SYSTEM
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NKB
2011-07-06
VIPER SYSTEMS
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NKB
2011-07-06
REVLOK FENESTRATED SCREW SYSTEM
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NKB
2011-06-08
TSRH SPINAL SYSTEM
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NKB
2011-05-25
LEUCADIA PEDICLE SCREW SYSTEM
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NKB
2011-05-23
TSRH SPINAL SYSTEM
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NKB
2011-05-12
STREAMLINE TL SPINAL SYSTEM
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NKB
2011-05-05
ISSYS LP SPINAL FIXATION SYSTEM
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NKB
2011-04-01
EXPEDIUM SYSTEM, VIPER SYSTEM
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NKB
2011-03-25
LANX SPINAL SYSTEM
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NKB
2011-03-25
SYNTEC OS SPINAL FIXATION SYSTEM
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NKB
2011-03-17
REVERE SACRAL PLATES
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NKB
2011-03-07
QUANTUM SPINAL SYSTEM, QUANTUM MIS
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NKB
2011-03-04
TRIO TRAUMA SPINAL SYSTEM
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NKB
2011-03-02
LAGUNA PEDICLE SCREW SYSTEM
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NKB
2011-02-17
EXPEDIUM SPINE SYSTEM, MOSS MIAMI SPINE SYSTEM
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NKB
2011-02-17
SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM
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NKB
2011-02-08
LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)
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NKB
2011-01-18
VEPER SYSTEM, EXPEDIUM SYSTEM
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NKB
2011-01-05
SYNTHES 6.0 COCR AND CPT TI-3 RODS
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NKB
2010-12-23
TSRH SPINAL SYSTEM
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NKB
2010-12-16
EXPEDIUM SPINE SYSTEM
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