Panels › Orthopedic › Product code MNI · Class 2
Orthosis, Spinal Pedicle Fixation
Regulation 888.3070
0510(k)s in 12 months (303 all time)
1recalls in 12 months (213 all time)
212recalls that name a 510(k)
Top companies in MNI
| Company | 510(k)s | Recalls |
|---|---|---|
| Valorem Surgical LLC | 0 | 144 |
| Allez Spine, LLC | 1 | 27 |
| Medtronic Sofamor Danek | 25 | 0 |
| K2m, Inc. | 15 | 0 |
| Spine Wave, Inc. | 11 | 0 |
| Blackstone Medical, Inc. | 7 | 3 |
| Stryker Spine | 7 | 2 |
| Spinal USA | 8 | 0 |
| Spinal Solutions, LLC | 0 | 8 |
| Life Spine | 7 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 20, 2013 | SpineFrontier, Inc. PedFuse Reset Screw Inserters; PedFuse Screw Inserter 08-9 REset Part# 11-80113
The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw c Terminated |
MNI | K123164 |
| Dec 20, 2013 | SpineFrontier, Inc. PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REspond Part# 11-80111
The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw Terminated |
MNI | K123164 |
| Dec 20, 2013 | SpineFrontier, Inc. PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110
The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw c Terminated |
MNI | K123164 |
| Dec 19, 2013 | SpineFrontier, Inc. PedFuse Reset Screw; Model: 01-80115-55
The PedFuse Reset pedicle screw implants intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the Terminated |
MNI | K123164 |
| Aug 9, 2013 | Synthes USA HQ, Inc. 5.0mm Unit Rod 270mm
5.0mm Unit Rod 290mm
5.0mm Unit Rod 310mm
5.0mm Unit Rod 330mm
5.0mm Unit Rod 350mm
5.0mm Unit Rod 370mm
5.0mm Unit Rod 390mm
5.0mm Unit Rod 410mm
5.0mm Unit Rod 430mm
5.0mm Unit Terminated |
MNI | K020517 |
| Jul 16, 2013 | SpineFrontier, Inc. KRD1 PedFuse Rods, Model: IM80100-13 Rev B
Product Usage: Pedicle rods are cylindrical rods which act as a linking mechanism between pedicle screws. The rod sits with the pedicle screw tulip and th Terminated |
MNI | K092420 |
| May 27, 2013 | Spinal Solutions, LLC 14 x 11 x 6mm 7 deg
14 x 11 x 7mm 7 deg
14 x 11 x 8mm 7 deg
14 x 11 x 9mm 7 deg
14 x 11 x 10mm 7 deg
14 x 11 x 11mm 7 deg
14 x 11 x 12mm 7 deg
Product Usage:
Spinal Solutions distributes a var Terminated |
MNI | K110633 |
| May 27, 2013 | Spinal Solutions, LLC 12mm x 27mm x 8mm
12mm x 27mm x 9mm
12mm x 27mm x 10mm
12mm x 27mm x 11mm
12mm x 27mm x 12mm
12mm x 27mm x 13mm
12mm x 27mm x 14mm
Product Usage:
Spinal Solutions distributes a variety of spina Terminated |
MNI | K110633 |
| May 27, 2013 | Spinal Solutions, LLC 60 mm Rod, Item #BG1660
Product Usage:
Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and su Terminated |
MNI | K110633 |
| May 27, 2013 | Spinal Solutions, LLC 50 mm Rod, Item #BG1650
Product Usage:
Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and su Terminated |
MNI | K110633 |
| May 27, 2013 | Spinal Solutions, LLC 40 mm Rod, Item #BG1640
Product Usage:
Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and su Terminated |
MNI | K110633 |
| May 27, 2013 | Spinal Solutions, LLC Set Screw, Item #BG3010
Product Usage:
Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and su Terminated |
MNI | K110633 |
| May 27, 2013 | Spinal Solutions, LLC 50 mm Screw, Item #BG7050
Product Usage:
Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and Terminated |
MNI | K110633 |
| May 27, 2013 | Spinal Solutions, LLC 45 mm Screw, Item #BG7045
Product Usage:
Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and Terminated |
MNI | K110633 |
| Apr 22, 2013 | Orthopedic Alliance LLC Orthopedic Alliance Spine System (alias "Blue & Gold")
Part Numbers:
BGC3010 Screw Cap
BGR0040 Straight Rod 5.5 x 40mm
BGR0050 Straight Rod 5.5 x 50mm
BGR0060 Straight Rod 5.5 x 60mm
BGR0070 Straigh Terminated |
MNI | K033826 |
| Nov 21, 2012 | Captiva Spine, Inc CapLOX II Final Torque Driver, Indicator is a Pedicle screw spinal system.
The CapLOX II Spinal System is a posterior, non-cervical pedicle fixation system intended to provide immobilization and stab Terminated |
MNI | K120292 |
| Aug 22, 2012 | Stryker Spine The Instructions For Use for the following:
Stryker TRIO+ 4.5 x 45 mm STANDARD POST SCREW
Stryker TRIO+ 4.5 x 50 mm STANDARD POST SCREW
Stryker TRIO+ 4.5 x 55 mm STANDARD POST SCREW
Stryker TRIO+ 5.5 Terminated |
MNI | K062698 |
| Jul 20, 2012 | Synthes (USA) Products LLC Universal Spinal System Lamina Hooks
Synthes Medium TI Lamina Hook - Right
498.320
Non sterile
LOT 6876785
Noncervical spinal fixation devices intended for posterior pedicle screw fixation, posterio Terminated |
MNI | K020517 |
| Aug 31, 2010 | Zimmer Inc. Abbott Spine PathFinder, Cannulated Poly Screwdriver II - MOD, non-sterile, Manufactured by Abbott Spine, Inc., Austin, TX; Ref. 1160-2.
Usage: The screwdriver is intended to mate to the hexalobular Terminated |
MNI | K030625 K071174 |
| Mar 16, 2010 | Blackstone Medical, Inc. Ascent Posterior Occipital Cervical Thoracic System, Single Looped Cable with Two Crimps, One Each. Distributed by Blackstone Medical, Springfield, MA.
Intended to promote fusion of the cervical spin Terminated |
MNI | K030197 |
| Sep 22, 2009 | EBI, L.P. Fixed Closed Screw (Ti);
6.0MM (D) x 40 MM (L)
Made In USA, Biomet Spine, Parsippany, NJ 07054
The screw devices are an internal fixation device intended to aid in the alignment and stabilization of Terminated |
MNI | K993956 |
| Jul 6, 2009 | Blackstone Medical, Inc. Blackstone Medical:
ICON Modular Pedicle Screw System;
P/N's 54-9011 (implant set), 54-9020 (instrument case# I), 54-9030 (instrument case #2), spinal implants. Terminated |
MNI | K042514 |
| Apr 10, 2009 | Stryker Spine Stryker Trio Small Offset Connector
Non Sterile; Manufactured by Stryker Spine SAS, Z.I. Marticot -33610- Cestas, France. Distributed in USA by Howmedica Osteonics Corp., Mahwah, NJ.
The Trio Spinal Terminated |
MNI | K052971 |
| Mar 12, 2009 | Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK Medtronic TSRH Spinal System, 3Dx Splined Connector, Large; Medtronic Sofamor Danek, Memphis, TN; REF 8351512.
The device is intended for orthosis, spinal pedicle fixation for degenerative disc disea Terminated |
MNI | K072317 |
| Mar 12, 2009 | Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK Medtronic TSRH Spinal System, 3Dx Splined Connector, Medium; Medtronic Sofamor Danek, Memphis, TN; REF 8351511.
The device is intended for orthosis, spinal pedicle fixation for degenerative disc dise Terminated |
MNI | K072317 |
| Mar 12, 2009 | Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK Medtronic TSRH Spinal System, 3Dx Splined Connector, Small; Medtronic Sofamor Danek, Memphis, TN; REF 8351510.
The device is intended for orthosis, spinal pedicle fixation for degenerative disc disea Terminated |
MNI | K072317 |
| Mar 12, 2009 | Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK Medtronic TSRH 3DX Implant Set; SPS002058. Sets are unlabeled, but contain individually labeled 3Dx Splined Connectors in sizes small, medium and large.
The device is intended for orthosis, spinal Terminated |
MNI | K072317 |
| Oct 28, 2008 | Allez Spine, LLC Allez Spine Laguna Pedicle Screw System; Catalog Number: IT-FN1003
Del Mar Pedicle Screw System; IT-ST1001Vertebrae Rotation Tool;
IT-H W1001Hex Wrench; IT-CB1001Coronal Bender-L; IT-CB1002 Coronal Be Terminated |
MNI | K050060 |
| Sep 17, 2008 | Allez Spine, LLC Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 7 x 45mm, Winged, Catalog # LG-PW0745 Terminated |
MNI | K050060 K051275 |
| Sep 17, 2008 | Allez Spine, LLC Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 7 x 40mm, Winged, Catalog # LG-PW0740 Terminated |
MNI | K050060 K051275 |
| Sep 17, 2008 | Allez Spine, LLC Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 7 x 35mm, Winged, Catalog # LG-PW0735 Terminated |
MNI | K050060 K051275 |
| Sep 17, 2008 | Allez Spine, LLC Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 6 x 45mm, Winged, Catalog # LG-PW0645 Terminated |
MNI | K050060 K051275 |
| Sep 17, 2008 | Allez Spine, LLC Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 6 x 40mm, Winged, Catalog # LG-PW0640 Terminated |
MNI | K050060 K051275 |
| Sep 17, 2008 | Allez Spine, LLC Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 6 x 35mm, Winged, Catalog # LG-PW0635 and Screw Size (diameter x length) 6 x 55mm, Winged, Catalog # LG-PW0655 Terminated |
MNI | K050060 K051275 |
| Sep 17, 2008 | Allez Spine, LLC Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 5 x 45mm, Winged, Catalog # LG-PW0545 Terminated |
MNI | K050060 K051275 |
| Sep 17, 2008 | Allez Spine, LLC Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 5 x 40mm, Winged, Catalog # LG-PW0540 Terminated |
MNI | K050060 K051275 |
| Sep 17, 2008 | Allez Spine, LLC Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 5 x 35mm, Winged, Catalog # LG-PW0535 Terminated |
MNI | K050060 K051275 |
| Sep 17, 2008 | Allez Spine, LLC Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 7 x 45mm, Non-winged, Catalog # LG-PR0745 Terminated |
MNI | K050060 K051275 |
| Sep 17, 2008 | Allez Spine, LLC Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 7 x 40mm, Non-winged, Catalog # LG-PR0740 Terminated |
MNI | K050060 K051275 |
| Sep 17, 2008 | Allez Spine, LLC Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 7 x 35mm, Non-winged, Catalog # LG-PR0735 and Screw Size (diameter x length) 7 x 50mm, Non-winged, Catalog # LG-PR07 Terminated |
MNI | K050060 K051275 |
| Sep 17, 2008 | Allez Spine, LLC Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 6 x 50mm, Non-winged, Catalog # LG-PR0650 Terminated |
MNI | K050060 K051275 |
| Sep 17, 2008 | Allez Spine, LLC Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 6 x 40mm, Non-winged, Catalog # LG-PR0640 Terminated |
MNI | K050060 K051275 |
| Sep 17, 2008 | Allez Spine, LLC Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 6 x 35mm, Non-winged, Catalog # LG-PR0635 Terminated |
MNI | K050060 K051275 |
| Sep 17, 2008 | Allez Spine, LLC Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 6 x 30mm, Non-winged, Catalog # LG-PR0630 Terminated |
MNI | K050060 K051275 |
| Sep 17, 2008 | Allez Spine, LLC Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 5 x 45mm, Non-winged, Catalog # LG-PR0545 Terminated |
MNI | K050060 K051275 |
| Sep 17, 2008 | Allez Spine, LLC Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 5 x 35mm, Non-winged, Catalog # LG-PR0535 Terminated |
MNI | K050060 K051275 |
| Sep 17, 2008 | Allez Spine, LLC Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 5 x 30mm, Non-winged, Catalog # LG-PR0530 Terminated |
MNI | K050060 K051275 |
| Sep 2, 2008 | Allez Spine, LLC Allez Spine Laguna Pedicle Screw System: IT-FN1001, Laguna Sterilization Tray # 1 (Part Number: 54003); IT-FN1002, Laguna Sterilization Tray # 2 (Part Number: 54004) Terminated |
MNI | K050060 |
| Sep 1, 2008 | Abbott Spine PathFinder Spinal Fixation System T-Handle Driver; Part 2151-7 (13" shaft); Non-sterile, Reusable Instrument; manufactured by Abbott Spine, Austin, TX 78727. Terminated |
MNI | K030625 K071174 |
| Sep 1, 2008 | Abbott Spine InCompass Spinal Fixation System T-Handle Driver; Part #2151-4 (9.5" shaft) and 2151-5 (13" shaft); Non-sterile, Reusable Instrument; manufactured by Abbott Spine, Austin, TX 78727. Terminated |
MNI | K021564 K023644 |
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