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)
Top companies in NKB
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Sofamor Danek | 98 | 2 |
| Depuy Spine, Inc. | 30 | 10 |
| Nuvasive, Inc. | 9 | 31 |
| Spinal Elements, Inc. | 11 | 22 |
| Stryker Spine | 22 | 5 |
| Alphatec Spine, Inc. | 20 | 5 |
| Zimmer Biomet, Inc. | 0 | 25 |
| Globus Medical, Inc. | 24 | 0 |
| Life Spine | 22 | 0 |
| K2m | 20 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 5, 2020 | Zimmer 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 |
NKB | K183550 |
| May 5, 2020 | Zimmer 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 |
NKB | K182550 |
| May 5, 2020 | Zimmer 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 |
NKB | K183550 |
| May 5, 2020 | Zimmer 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 |
NKB | K183550 |
| May 5, 2020 | Zimmer 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 |
NKB | K183550 |
| Nov 11, 2019 | Medicrea International Medicrea International Universal Counter Torque for use with the Pass TULIP [Spinal] System
Ref : A22020500 Terminated |
NKB | K190376 |
| Jul 1, 2019 | Clariance 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 |
NKB | K153326 |
| Jun 27, 2019 | Medicrea 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 |
NKB | K141398 |
| Jun 18, 2019 | Howmedica Osteonics Corp. Serrato 9.5mm X 90mm Polyaxial Screw
Catalog Number 482619590
Serrato 9.5mm X 100mm Polyaxial Screw
Catalog Number 4826195100 Terminated |
NKB | K170496 |
| Mar 20, 2019 | CTL Medical Corporation CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting Ref 019.7050 Terminated |
NKB | K132365 |
| Feb 22, 2019 | Zimmer 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 |
NKB | K150896 K171907 |
| Jul 9, 2018 | Medtronic 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 |
NKB | K113174 |
| Jun 29, 2018 | Back 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 |
NKB | K150184 |
| Jan 8, 2018 | Innovasis, 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 |
NKB | K102248 |
| Aug 18, 2017 | Orthofix, 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 |
NKB | K171082 |
| Jul 7, 2017 | Amendia, Inc Mac Pin Non-Cannulated Screw, 6.5 x 60mm Terminated |
NKB | K153152 |
| May 5, 2017 | Alphatec 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 |
NKB | K133221 |
| Nov 16, 2016 | Alphatec 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 |
NKB | K133221 |
| Feb 12, 2016 | Zimmer 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 |
NKB | K111301 K113270 +2 |
| Feb 12, 2016 | Zimmer 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 |
NKB | None listed |
| Jan 19, 2016 | Innovasis, 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 |
NKB | K102248 K140238 |
| Nov 10, 2015 | OrthoPediatrics 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 |
NKB | K150600 |
| Sep 25, 2015 | Stryker 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 |
NKB | None listed |
| Jul 20, 2015 | Biomet 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 |
NKB | K133746 |
| Jun 10, 2015 | Orthofix, 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 |
NKB | K130932 |
| May 26, 2015 | DePuy 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 |
NKB | K101070 K111136 +1 |
| May 11, 2015 | Spinal 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 |
NKB | K071914 |
| Feb 24, 2015 | Biomet 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 |
NKB | K122145 |
| Feb 11, 2015 | Biomet 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 |
NKB | None listed |
| Jan 5, 2015 | Ebi, 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 |
NKB | K123549 |
| Nov 26, 2014 | Synthes (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 |
NKB | K100952 |
| Sep 22, 2014 | Genesys 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 |
NKB | K100757 |
| Sep 9, 2014 | PIONEER 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 |
NKB | K130286 |
| Aug 11, 2014 | Integra 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 |
NKB | K083089 |
| Jul 22, 2014 | Alphatec 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 |
NKB | K131119 |
| Jul 16, 2014 | Innovasis, 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 |
NKB | K102248 K140238 |
| Jul 1, 2014 | Integra 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 |
NKB | K083089 |
| Jun 20, 2014 | SeaSpine 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 |
NKB | K043232 |
| Feb 7, 2014 | Integra 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 |
NKB | K051942 K061342 |
| Nov 26, 2013 | Synthes 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 |
NKB | K113044 |
| Nov 26, 2013 | Synthes 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 |
NKB | K113044 |
| Aug 27, 2013 | Alphatec 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 |
NKB | K123623 |
| Jul 29, 2013 | Custom 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 |
NKB | K070281 K072866 +1 |
| May 28, 2013 | Alphatec Spine, Inc. Leucadia Autolok" Polyaxial Pedicle Screw System.
Intended to help provide correction, immobilization and stabilization of spinal segments. Terminated |
NKB | K113366 |
| May 7, 2013 | Spinal 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 |
NKB | K071914 |
| May 7, 2013 | Spinal 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 |
NKB | K071914 |
| May 7, 2013 | Spinal 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 |
NKB | K071914 |
| May 7, 2013 | Spinal 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 |
NKB | K071914 |
| May 7, 2013 | Spinal 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 |
NKB | K071914 |
| May 7, 2013 | Spinal 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 |
NKB | K071914 |
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