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) |
|---|---|---|---|
| Nov 19, 2012 | NuVasive Inc 5.5mm x 45mm Cannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 5.5mm x 40mm Cannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 5.5mm x 35mm Cannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 5.5mm x 30mm Cannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc Screw Tulip , 6.25mm Rod
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Oct 1, 2012 | Synthes 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 |
NKB | K113044 |
| Sep 7, 2012 | Aesculap 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 |
NKB | K100623 |
| Aug 27, 2012 | Atlas 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 |
NKB | K072426 |
| Jul 10, 2012 | Zimmer, 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 |
NKB | K100845 |
| Jul 10, 2012 | Zimmer, 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 |
NKB | K100845 |
| Jul 3, 2012 | Zimmer, 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 |
NKB | K100845 |
| Jun 5, 2012 | Stryker 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 |
NKB | K071373 |
| Sep 15, 2011 | Synthes 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 |
NKB | K092929 K100952 |
| Sep 7, 2011 | Orthofix, 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 |
NKB | K092624 |
| Jul 25, 2011 | Medtronic 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 |
NKB | K091974 |
| Mar 16, 2011 | Orthofix 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 |
NKB | K081684 |
| Mar 8, 2011 | Orthofix 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 |
NKB | K081684 |
| Oct 22, 2010 | Ebi, Llc ARRAY and POLARIS Spinal System Medium Cross Connector
Non Sterile
Biomet Spine, Parsippany, NJ. 07054 Terminated |
NKB | K062685 |
| Oct 18, 2010 | Zimmer 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 |
NKB | K030625 K071174 |
| Feb 24, 2010 | Stryker 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 |
NKB | K083393 |
| Dec 22, 2009 | Zimmer Inc. Zimmer / Abbott Spine Sequoia dorsal height & revision tool, non-sterile; REF 3367-1. Surgical instrument for pedicle screw system. Terminated |
NKB | K082032 |
| Jun 26, 2009 | Stryker 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 |
NKB | K060361 |
| Oct 28, 2008 | Allez 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 |
NKB | K070460 |
| Oct 28, 2008 | Allez 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 |
NKB | K051275 |
| Sep 5, 2008 | Abbott Spine PathFinder Cannulated T-Handle Bone Awl, Part Number 1155-2; distributed by Abbott Spine, Inc., Austin, TX 78727. Terminated |
NKB | K030625 K071174 |
| Sep 2, 2008 | Allez Spine, LLC Allez Spine Del Mar Pedicle Screw System: IT-FN 1007, Del Mar Sterilization Tray (Part Number: 30013) Terminated |
NKB | K051275 |
| Jul 23, 2008 | Abbott 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 |
NKB | K072672 |
| Oct 2, 2007 | Abbott Spine PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60. Terminated |
NKB | K030625 |
| Oct 2, 2007 | Abbott Spine PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50. Terminated |
NKB | K030625 |
| Sep 21, 2007 | Stryker 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 |
NKB | K062270 |
| Oct 7, 2005 | Pioneer Surgical Technology Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog number 10-575-PA-40. Terminated |
NKB | K041167 |
| Oct 7, 2005 | Pioneer Surgical Technology Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45. Terminated |
NKB | None listed |
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