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
2017-02-09
NKB
2017-02-02
ProMIS™ Fixation System
View details →
NKB
2017-01-25
PASS LP Spinal System
View details →
NKB
2017-01-23
Facilis™ Spinal System
View details →
NKB
2017-01-19
JAZZ FRAME SYSTEM
View details →
NKB
2016-12-20
CD HORIZON® Spinal System
View details →
NKB
2016-12-14
ENNOVATE Spinal System
View details →
NKB
2016-12-08
VIPER PRIME™ additions to the VIPER® System
View details →
NKB
2016-11-18
Preference Elite Pedicle Screw System
View details →
NKB
2016-11-17
MOSS 100 Pedicle Screw System
View details →
NKB
2016-11-16
CD HORIZON® Spinal System
View details →
NKB
2016-11-10
FORTEZZA Spinal Stabilization System
View details →
NKB
2016-10-27
Libra Pedicle Screw System
View details →
NKB
2016-10-27
Erisma® LP MIS
View details →
NKB
2016-10-21
M.U.S.T. Pedicle Screw System
View details →
NKB
2016-10-13
Overwatch Spine System
View details →
NKB
2016-10-04
CD HORIZON® Spinal System
View details →
NKB
2016-09-28
NuVasive® Reline® System
View details →
NKB
2016-09-23
PASS XS Spinal System
View details →
NKB
2016-09-08
SeaSpine® NewPort™ Spinal System
View details →
NKB
2016-08-25
G Surgical Marksman MIS System
View details →
NKB
2016-08-22
PathLoc-L MIS Spinal System
View details →
NKB
2016-08-09
Genesys Spine TiLock Cortical Spinal System
View details →
NKB
2016-08-04
Mont Blanc and Mont Blanc MIS Spinal Systems
View details →
NKB
2016-07-29
PASS LP Spinal System
View details →
NKB
2016-07-29
VertiForm Posterior Fixation System
View details →
NKB
2016-07-21
EVEREST Spinal System
View details →
NKB
2016-07-15
Threshold™ Pedicular Fixation System
View details →
NKB
2016-07-08
Savannah-T® Pedicle Screw System
View details →
NKB
2016-07-07
CorticaLINK Spinal Fusion Platform
View details →
NKB
2016-07-01
Expedium Spine System, VIPER and VIPER 2 Systems
View details →
NKB
2016-06-28
F1 MPS Modular Pedicle Screw System
View details →
NKB
2016-06-28
PressON Pro Spinal Fixation System
View details →
NKB
2016-06-10
Arsenal Spinal Fixation System
View details →
NKB
2016-06-09
NuVasive® Reline® System
View details →
NKB
2016-06-03
Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems
View details →
NKB
2016-05-26
Threshold Pedicular Fixation System, Palisade Pedicular Fixation System
View details →
NKB
2016-05-26
Mariner Pedicle Screw System
View details →
NKB
2016-05-18
JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector
View details →
NKB
2016-05-04
Xenco Medical Pedicle Screw System
View details →
NKB
2016-04-27
Syzygy Stabilization System
View details →
NKB
2016-04-26
Inertia Pedicle Screw and Deformity Correxxion System
View details →
NKB
2016-04-22
Revolution Spinal Fixation System
View details →
NKB
2016-04-22
PASS LP Spinal System
View details →
NKB
2016-04-13
Diplomat® Spinal System
View details →
NKB
2016-04-12
icotec Pedicle System
View details →
NKB
2016-03-23
Response 5.5 Spine System
View details →
NKB
2016-03-08
Erisma-LP Spinal Fixation System
View details →
NKB
2016-02-23
Palisade Pedicular Fixation System
View details →
NKB
2016-02-18
CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with the STEALTHSTATION System, Medtronic Reusable Instruments for Use with the IPC POWEREASE System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION and IPC POWEREASE Systems
View details →
NKB
2016-02-12
Adena-Zina System
View details →
NKB
2016-02-10
CD HORIZON Spinal System
View details →
NKB
2016-01-29
Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System
View details →
NKB
2016-01-28
Seneka II Polyscrew Pedicle Fixation System
View details →
NKB
2016-01-19
M.U.S.T. Pedicle Screw System
View details →
NKB
2013-12-18
M.U.S.T. EXTENSION
View details →
NKB
2013-12-17
ST360 DEGREES SPINAL FIXATION SYSTEM
View details →
NKB
2013-12-17
MANTIS & MANTIS REDUX SPINAL SYSTEM, RADIUS SPINAL SYSTEM, TRIO & TRIO+ SPINAL FIXATION SYSTEMS, AND TRIO TRAUMA SPINAL
View details →
NKB
2013-12-06
CD HORIZON SPINAL SYSTEM
View details →
NKB
2013-11-27
TITLE 2 POLYAXIAL SPINAL SYSTEM
View details →
NKB
2013-11-25
PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM
View details →
NKB
2013-11-25
CD HORIZON SPINAL SYSTEM
View details →
NKB
2013-11-20
APEX SPINE SYSTEM
View details →
NKB
2013-10-31
GSB GLOBAL SPINAL BALANCE SYSTEM
View details →
NKB
2013-10-28
NAUTILUS SPINAL SYSTEM
View details →
NKB
2013-10-08
CD HORIZON SPINAL SYSTEM
View details →
NKB
2013-10-03
NAUTILUS SPINAL SYSTEM
View details →
NKB
2013-09-10
TIGER SPINE SYSTEM
View details →
NKB
2013-09-04
SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM
View details →
NKB
2013-08-23
LLIAD, KORA, ZENIUS PEDICLE SCREW SYSTEM
View details →
NKB
2013-08-20
PAGODA PEDICLE SCREW SYSTEM
View details →
NKB
2013-08-07
FIREBIRD SPINAL FIXATION SYSTEM
View details →
NKB
2013-08-06
CD HORIZON SPINAL SYSTEM
View details →
NKB
2013-06-27
STREAMLINE TL SPINAL SYSTEM
View details →
NKB
2013-06-20
EXPEDIUM SPINE SYSTEM
View details →
NKB
2013-05-21
SOLANAS POSTERIOR STABILIZATION SYSTEM
View details →
NKB
2013-05-03
STERISPINE PS PEDICLE SCREW
View details →
NKB
2013-04-19
INSTINCT JAVA SYSTEM
View details →
NKB
2013-04-11
S4 SPINAL SYSTEM
View details →
NKB
2013-04-10
CD HORIZON SPINAL SYSTEM
View details →
NKB
2013-04-01
STREAMLINE MIS SPINAL FIXATION SYSTEM
View details →
NKB
2013-03-28
FIREBIRD SPINAL FIXATION SYSTEM
View details →
NKB
2013-03-12
S4 SPINAL SYSTEM
View details →
NKB
2013-03-06
NAUTILUS SPINAL SYSTEM
View details →
NKB
2013-03-04
UCENTUM
View details →
NKB
2013-02-25
POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM
View details →
NKB
2013-02-22
CD HORIZON SPINAL SYSTEM
View details →
NKB
2013-02-14
ILLICO MIS POSTERIOR FIXATION SYSTEM
View details →
NKB
2013-02-01
EASYSPINE SYSTEM
View details →
NKB
2013-01-25
MEDYSSEY CANNULATED PEDICLE SCREW
View details →
NKB
2012-12-12
S4 SPINAL SYSTEM
View details →
NKB
2012-12-12
MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEM
View details →
NKB
2012-12-07
ES2 SPINAL SYSTEM MODEL 48280XXXX
View details →
NKB
2012-12-03
POLARIS SPINAL SYSTEM - BALLISTA II RODS
View details →
NKB
2012-12-03
FIREBIRD SPINAL FIXATION SYSTEM, PHOENIX MIS SPINAL FIXATION SYSTEM
View details →
NKB
2012-11-20
VICEROY SPINAL SYSTEM
View details →
NKB
2012-11-16
CD HORIZON SPIRE Z SPINAL SYSTEM
View details →
NKB
2012-11-05
DYMAXEON SPINE SYSTEM
View details →
NKB
2012-10-05
TIGER SPINE SYSTEM
View details →
NKB
2012-10-03
CD HORIZON SPINAL SYSTEM
View details →No matching devices.
Advertisement