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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)
Nov 19, 2012NuVasive Inc
5.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Terminated
NKBK082332
Nov 19, 2012NuVasive Inc
5.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Terminated
NKBK082332
Nov 19, 2012NuVasive Inc
5.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Terminated
NKBK082332
Nov 19, 2012NuVasive Inc
5.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Terminated
NKBK082332
Nov 19, 2012NuVasive Inc
Screw Tulip , 6.25mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI
Terminated
NKBK082332
Oct 1, 2012Synthes USA HQ, Inc.
MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended
Terminated
NKBK113044
Sep 7, 2012Aesculap Implant Systems LLC
Aesculap S4 Element 4.5mm Polyaxial Screws (ST240T, ST241T, ST242T, ST243T, ST244T, and ST245T). The S4 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and no
Terminated
NKBK100623
Aug 27, 2012Atlas Spine, Inc.
Apelo Modular Screwdriver labeled in part: "APELO PEDICLE SCREW SYSTEM***Modular Screwdriver***Atlas Spine, Inc.***www.AtlasSpine.com*** 1555 Jupiter Park Drive #4***Jupiter, Florida 33458***561-741-1
Terminated
NKBK072426
Jul 10, 2012Zimmer, Inc.
Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-2 (straight handle) Stainless Steel / Silicone Rubber, Rx only, non sterile. Product Usage: PathFinder NXT is a minimally invasive pedi
Terminated
NKBK100845
Jul 10, 2012Zimmer, Inc.
Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-1 (angle handle) , Stainless Steel / Silicone Rubber, Rx only, non sterile. Product Usage: The rod is held by the instrument for insert
Terminated
NKBK100845
Jul 3, 2012Zimmer, Inc.
PathFinder NXT Pivoting Percutaneous Rod Holder This device is an instrument used during orthopedic surgery. The intended use of the pivoting percutaneous rod holder is to attach to the rod to facili
Terminated
NKBK100845
Jun 5, 2012Stryker Spine
Stryker Xia 3 Anti-Torque Key Manual Surgical Instrument; Catalog Number 48237026. Product Usage: : Reusable instrument used to aid in the final tightening of the spinal construct. Intended Use:
Terminated
NKBK071373
Sep 15, 2011Synthes USA (HQ), Inc.
Synthes T1 Matrix Locking Cap of the Synthes Matrix System, Part Number 04.632.000. Intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation.
Terminated
NKBK092929
K100952
Sep 7, 2011Orthofix, Inc.
Ratcheting Torque Limiting Handle, Catalog Number 52-1012, Orthofix Spinal Implants, Firebird Spinal Fixation System, Firebird Spinal Fixation System DDD Instrument Case. Product is intended for use
Terminated
NKBK092624
Jul 25, 2011Medtronic Sofamor Danek USA Inc
CD HORIZON (R) SOLERA (TM) FAS, REF 54410006035, pedicle screw, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 Intended to help provide immobilization and stabilization
Terminated
NKBK091974
Mar 16, 2011Orthofix Inc
BLACKSTONE Medical Inc. Firebird Spinal Fixation System 6.5mm x 30mm Bone Screw, Self Tapping, Cannulated. BLACKSTONE Medical Inc. Firebird Spinal Fixation System 6.5mm x 30mm Multi-Axial Screw, Self
Terminated
NKBK081684
Mar 8, 2011Orthofix Inc
ORTHOFIX Firebird Spinal Fixation System, Pedicle Screw Spinal System, Reduction Case, Part #68-0111, Lot #16518-LC18. Intended for use in conjunction with Multi-Axial Reduction Screw Assemblies. Dur
Terminated
NKBK081684
Oct 22, 2010Ebi, Llc
ARRAY and POLARIS Spinal System Medium Cross Connector Non Sterile Biomet Spine, Parsippany, NJ. 07054
Terminated
NKBK062685
Oct 18, 2010Zimmer Inc.
Pathfinder End Screw Extender Sleeve, REF 1165-10, Rx, non-sterile, sold under label Abbott Spine, Inc. Austin TX (prior to 2008) and Zimmer Spine Austin TX (7/2009 to present)
Terminated
NKBK030625
K071174
Feb 24, 2010Stryker Spine
Stryker XIA 3 Polyaxial Screw, 8.5mm x 65 mm. Catalog Number: 482318565. Not Sterile; Manufactured by Stryker Spine, SA, Cestas, France. Distributed in the USA by Stryker Spine, Allendale, NJ Inte
Terminated
NKBK083393
Dec 22, 2009Zimmer Inc.
Zimmer / Abbott Spine Sequoia dorsal height & revision tool, non-sterile; REF 3367-1. Surgical instrument for pedicle screw system.
Terminated
NKBK082032
Jun 26, 2009Stryker Spine
Stryker Xia Dual Anterior Staple; Non Sterile; Catalog number 03820115; Manufactured by Stryker Spine SAS, Cestas, France; Distributed by Howmedica Osteonics Corp, Mahwah, NJ 07430 Single use device
Terminated
NKBK060361
Oct 28, 2008Allez Spine, LLC
Allez Spine Cross Connectors; Catalog Number: LG-CC1001Cross Link, Small 30-37mm; LG-CC1002 Cross Link, Medium 37-50mm; LG-CC1003 Cross Link, Lange 50-80mm; lT-T01003 Cross Link Torque Hex Driver, 2.5
Terminated
NKBK070460
Oct 28, 2008Allez Spine, LLC
Allez Spine Del Mar Pedicle Screw System; Catalog Number: IT-FN1001 Laguna Pedicle Screw System Tray #1; IT-FN 1002 Laguna Pedicle Screw System Tray #2; lT-CT1001Counter Torque (w/Large Rubber Handle)
Terminated
NKBK051275
Sep 5, 2008Abbott Spine
PathFinder Cannulated T-Handle Bone Awl, Part Number 1155-2; distributed by Abbott Spine, Inc., Austin, TX 78727.
Terminated
NKBK030625
K071174
Sep 2, 2008Allez Spine, LLC
Allez Spine Del Mar Pedicle Screw System: IT-FN 1007, Del Mar Sterilization Tray (Part Number: 30013)
Terminated
NKBK051275
Jul 23, 2008Abbott Spine
Sequoia Spinal System Surgical Kits; Pedicle screw spinal system; Non-sterile (kits intended to be sterilized prior to use); Rx Only; The Sequoia Spinal System is designed to aid in the surgical cor
Terminated
NKBK072672
Oct 2, 2007Abbott Spine
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.
Terminated
NKBK030625
Oct 2, 2007Abbott Spine
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
Terminated
NKBK030625
Sep 21, 2007Stryker Spine
Stryker Radius Locking Caps, Catalog Number: 486610000, Manufactured by Stryker Spine SAS Z.I. Marticot - 33610 Cestas France.,Distributed by Howmedica Osteonics Corp. 325 Corporate Drive, Mahway, NJ
Terminated
NKBK062270
Oct 7, 2005Pioneer Surgical Technology
Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog number 10-575-PA-40.
Terminated
NKBK041167
Oct 7, 2005Pioneer Surgical Technology
Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45.
Terminated
NKBNone listed

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