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Panels › Orthopedic › Product code NKB · Class 2

Thoracolumbosacral Pedicle Screw System

Regulation 888.3070

33510(k)s in 12 months (914 all time)
4recalls in 12 months (182 all time)
177recalls that name a 510(k)
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Top companies in NKB

DateFirm and productCodeLinked 510(k)
May 5, 2020Zimmer Biomet, Inc.
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X35MM, Item Number 810M5535 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, post
Terminated
NKBK183550
May 5, 2020Zimmer Biomet, Inc.
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X45MM, Item Number 810M4545 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, post
Terminated
NKBK182550
May 5, 2020Zimmer Biomet, Inc.
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X40MM, Item Number 810M4540 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, post
Terminated
NKBK183550
May 5, 2020Zimmer Biomet, Inc.
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X35MM, Item Number 810M4535 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, post
Terminated
NKBK183550
May 5, 2020Zimmer Biomet, Inc.
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X30MM, Item Number 810M4530 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, post
Terminated
NKBK183550
Nov 11, 2019Medicrea International
Medicrea International Universal Counter Torque for use with the Pass TULIP [Spinal] System Ref : A22020500
Terminated
NKBK190376
Jul 1, 2019Clariance Inc
Erisma- LP posterior fixation system with the below specifically affected products: 1. Erisma-LP polyaxial screws - 4.5, 5.5, 6.5, 7.5, 8.5, 9.5, 105 mm (all lengths); 2. Erisma-LP Screwdriver;
Terminated
NKBK153326
Jun 27, 2019Medicrea International
Medicrea Pass LP, REF B02217545, Non Sterile, Material: Ti-6Al-4V ELI, VIS PEDICULAIRE POLYAXIALE 7.5MM x 45MM, POLYAXIAL PEDICLE SCREW 7.5MM x 45 MM, POLYAXIAL PEDIKELSCHRAUBE 7.5MM X 45MM, TORNILLO
Terminated
NKBK141398
Jun 18, 2019Howmedica Osteonics Corp.
Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm Polyaxial Screw Catalog Number 4826195100
Terminated
NKBK170496
Mar 20, 2019CTL Medical Corporation
CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting Ref 019.7050
Terminated
NKBK132365
Feb 22, 2019Zimmer Biomet Spine Inc.
Vitality Spinal Fixation System. Thoracolumbosacral pedicle screw system (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use in Ortho
Terminated
NKBK150896
K171907
Jul 9, 2018Medtronic Sofamor Danek USA Inc
Medtronic CD HORIZON Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, or sacral spine.MULTI-AXIAL SCREW FO
Terminated
NKBK113174
Jun 29, 2018Back 2 Basics Direct LLC
Dymaxeon 5.5 Curved Rod Size 5.5 x 110mm (Yellow), Model Number 06.6441B Product Usage: The Dymaxeon Spine System is intended to provide immobilization and stabilization of spinal segments in skeleta
Terminated
NKBK150184
Jan 8, 2018Innovasis, Inc
Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in
Terminated
NKBK102248
Aug 18, 2017Orthofix, Inc
Firebird NXG Spinal Fixation System Decorticating Planer, Catalog #36-1334, non-sterile, Rx. .A Decorticating Planer is used to decorticate bone surrounding the spherical head of an implanted bone
Terminated
NKBK171082
Jul 7, 2017Amendia, Inc
Mac Pin Non-Cannulated Screw, 6.5 x 60mm
Terminated
NKBK153152
May 5, 2017Alphatec Spine, Inc.
Arsenal Spinal Fixation System, Set Screw, Part No. 47027 Product Usage: The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for t
Terminated
NKBK133221
Nov 16, 2016Alphatec Spine, Inc.
Arsenal Spinal Fixation System, Set Screw, Part No. 47127 Product Usage: Usage: The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for
Terminated
NKBK133221
Feb 12, 2016Zimmer Spine, Inc.
Instinct Java System (IFU reference: 046WAN0000T) . Stabilizes one or more vertebral segments from the thoracic spine to the sacrum during the development of bone tissue.
Terminated
NKBK111301
K113270 +2
Feb 12, 2016Zimmer Spine, Inc.
Universal Clamp System (IFU reference: SNA027-N-90001). Provides the stability required for solid bone fusion and helps reduce spinal deformities and fractures.
Terminated
NKBNone listed
Jan 19, 2016Innovasis, Inc
Excella II Rod Cat. No.: SR 55100 5.5 x 100 mm LOT 1502 and Excella II Rod Cat. No.: SR 55110 5.5 x 110 mm LOT 1502 Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization
Terminated
NKBK102248
K140238
Nov 10, 2015OrthoPediatrics Corp
UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw The Response 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature
Terminated
NKBK150600
Sep 25, 2015Stryker Spine
Stryker Radius 5.5 to 3.5 Rod to Red Connector, REF 48664530. Intended to provide additional support during fusion using autograft or allograft in skeletally mature patients.
Terminated
NKBNone listed
Jul 20, 2015Biomet Spine, LLC
Polaris 4.75 TI Spinal System, 4.0 x 20 MM, Closed MAS, Closed Head Multiaxial Screw, Non-Sterile, Rx Only, REF 14-583020, Biomet Spine and Bone Healing Technologies. Spinal fixation component.
Terminated
NKBK133746
Jun 10, 2015Orthofix, Inc
ORTHOFIX Firebird Spinal Fixation System 6.5mm x 55mm Multi-Axial Screw, Standard Implant Grade Titanium Alloy Rx Only Provided Non-Sterile Do Not Reuse
Terminated
NKBK130932
May 26, 2015DePuy Spine, Inc.
EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467
Terminated
NKBK101070
K111136 +1
May 11, 2015Spinal Elements, Inc
Spinal Elements 5.5 x 45MM Mercury lordosed rod. A component of the Mercury Spinal System, comprised of a variety of screws, hooks, rods, connectors, and staples that are used for attachment to the n
Terminated
NKBK071914
Feb 24, 2015Biomet Spine, LLC
Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy set screw is used to seat a 5.5 mm titanium alloy, commercially pure titanium or cobalt chrome rod into a pedicle screw tul
Terminated
NKBK122145
Feb 11, 2015Biomet Spine, LLC
Telluride Percutaneous Rod Inserter Long, Model #7706-1904. The Inserter is a reusable device provided within an aluminum sterilization case along with other orthopedic manual surgical instruments.
Terminated
NKBNone listed
Jan 5, 2015Ebi, Llc
Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and set screws. Various instruments are also available for use by the surgeon to facilitate implantation of the de
Terminated
NKBK123549
Nov 26, 2014Synthes (USA) Products LLC
Synthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws: The Titanium Polyaxial Reduction Head is a part of the Matrix Spine System. Intended for posterior pedicle screw fixation
Terminated
NKBK100952
Sep 22, 2014Genesys Orthopedics Systems, LLC
Circular Lock Screws, part # G826, lot # 11406. The Lock Screws are part of the Genesys Spine TiLock Pedicle Screw System. The TiLock Pedicle Screw System is intended to provide immobilization and st
Terminated
NKBK100757
Sep 9, 2014PIONEER SURGICAL TECHNOLOGY, INC.
Streamline MIS Spinal Fixation System Fixed Rod Holder NON STERILE, Rx only The Streamline MIS Spinal Fixation System is intended for posterior, noncervical pedicle fixation, T1-S2. Pedicle screw fi
Terminated
NKBK130286
Aug 11, 2014Integra LifeSciences Corp.
Integra NewPort MIS System Model No. NWPIMP (NewPort Implant Tray w/ Components) NWP2INSTP (NewPort Instrument Tray w/ Components) The NewPort System is intended to be used as a temporary or
Terminated
NKBK083089
Jul 22, 2014Alphatec Spine, Inc.
Solanas 2.1mm FIXED DEPTH DRILL, 10mm, Part No. 63928-10. Component of the SOLANAS III Posterior Stabilization System, a spinal fixation system intended to improve stability of the cervical and thora
Terminated
NKBK131119
Jul 16, 2014Innovasis, Inc
Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For spinal fixation. Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as
Terminated
NKBK102248
K140238
Jul 1, 2014Integra LifeSciences Corp.
MIS Rod 2, a component of the NewPort System. Model No: 60-0545 (45mm); 60-0550 (50mm); 60-0555 (55mm); 60-0560 (60mm); 60-0575 (75mm); 60-0580 (80mm). The NewPort MIS Rod 2 is a 5.5 diameter titani
Terminated
NKBK083089
Jun 20, 2014SeaSpine Inc
Integra UCR 3mm Hex, Large Axial Driver. The UCR Hex Axial Driver is a surgical instrument used to implant and remove polyaxial screws of varying reduction heights provided with the Malibu", UCR, and
Terminated
NKBK043232
Feb 7, 2014Integra LifeSciences Corp.
Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109; Malibu Polyaxial Screwdriver, Standard, Model Number 91-2110. 510(k): 91-2109 K061342. 91-2110 K051942. The Malibu" System is int
Terminated
NKBK051942
K061342
Nov 26, 2013Synthes USA HQ, Inc.
Synthes Titanium Minimally Invasive Reduction Screw System Locking Cap, Part Number 04.631.502 Non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixat
Terminated
NKBK113044
Nov 26, 2013Synthes USA HQ, Inc.
Synthes Titanium Minimally Invasive Reduction Screw System Polyaxial Screw Body, Part Number 04.631.500 Non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior h
Terminated
NKBK113044
Aug 27, 2013Alphatec Spine, Inc.
Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm. The Illico MIS Posterior Fixation System is intended to facilitate the surgical correction of noncervical spinal deformities by providing temporary i
Terminated
NKBK123623
Jul 29, 2013Custom Spine, Inc.
Custom Spine ISSYS LP Inverted Screw System. 8.5MM X 45 MM ISSYS LP Screw Rx Non-Sterile. Custom Spine, Inc. 9 Campus Dr. Parsippany, NJ 07054 USA. TEL: 973-808-0019 The ISSYS LP Spinal Fixation
Terminated
NKBK070281
K072866 +1
May 28, 2013Alphatec Spine, Inc.
Leucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide correction, immobilization and stabilization of spinal segments.
Terminated
NKBK113366
May 7, 2013Spinal Elements, Inc
Mercury Spinal System DIA 5.5 x 400mm Straight Rod, Part Number: 60101-400. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Terminated
NKBK071914
May 7, 2013Spinal Elements, Inc
Mercury Spinal System DIA 5.5 x 120mm Straight Rod, Part Number: 60101-120. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Terminated
NKBK071914
May 7, 2013Spinal Elements, Inc
Mercury Spinal System DIA 5.5 x 110mm Straight Rod, Part Number: 60101-110. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Terminated
NKBK071914
May 7, 2013Spinal Elements, Inc
Mercury Spinal System DIA 5.5 x 100mm Straight Rod, Part Number: 60101-100. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Terminated
NKBK071914
May 7, 2013Spinal Elements, Inc
Mercury Spinal System DIA 5.5 x 90mm Straight Rod, Part Number: 60101-090. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Terminated
NKBK071914
May 7, 2013Spinal Elements, Inc
Mercury Spinal System DIA 5.5 x 80mm Straight Rod, Part Number: 60101-080. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Terminated
NKBK071914

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