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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)
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Top companies in MNI

DateFirm and productCodeLinked 510(k)
Dec 20, 2013SpineFrontier, 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
MNIK123164
Dec 20, 2013SpineFrontier, 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
MNIK123164
Dec 20, 2013SpineFrontier, 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
MNIK123164
Dec 19, 2013SpineFrontier, 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
MNIK123164
Aug 9, 2013Synthes 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
MNIK020517
Jul 16, 2013SpineFrontier, 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
MNIK092420
May 27, 2013Spinal 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
MNIK110633
May 27, 2013Spinal 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
MNIK110633
May 27, 2013Spinal 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
MNIK110633
May 27, 2013Spinal 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
MNIK110633
May 27, 2013Spinal 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
MNIK110633
May 27, 2013Spinal 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
MNIK110633
May 27, 2013Spinal 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
MNIK110633
May 27, 2013Spinal 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
MNIK110633
Apr 22, 2013Orthopedic 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
MNIK033826
Nov 21, 2012Captiva 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
MNIK120292
Aug 22, 2012Stryker 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
MNIK062698
Jul 20, 2012Synthes (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
MNIK020517
Aug 31, 2010Zimmer 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
MNIK030625
K071174
Mar 16, 2010Blackstone 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
MNIK030197
Sep 22, 2009EBI, 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
MNIK993956
Jul 6, 2009Blackstone 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
MNIK042514
Apr 10, 2009Stryker 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
MNIK052971
Mar 12, 2009Warsaw 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
MNIK072317
Mar 12, 2009Warsaw 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
MNIK072317
Mar 12, 2009Warsaw 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
MNIK072317
Mar 12, 2009Warsaw 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
MNIK072317
Oct 28, 2008Allez 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
MNIK050060
Sep 17, 2008Allez Spine, LLC
Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 7 x 45mm, Winged, Catalog # LG-PW0745
Terminated
MNIK050060
K051275
Sep 17, 2008Allez Spine, LLC
Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 7 x 40mm, Winged, Catalog # LG-PW0740
Terminated
MNIK050060
K051275
Sep 17, 2008Allez Spine, LLC
Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 7 x 35mm, Winged, Catalog # LG-PW0735
Terminated
MNIK050060
K051275
Sep 17, 2008Allez Spine, LLC
Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 6 x 45mm, Winged, Catalog # LG-PW0645
Terminated
MNIK050060
K051275
Sep 17, 2008Allez Spine, LLC
Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 6 x 40mm, Winged, Catalog # LG-PW0640
Terminated
MNIK050060
K051275
Sep 17, 2008Allez 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
MNIK050060
K051275
Sep 17, 2008Allez Spine, LLC
Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 5 x 45mm, Winged, Catalog # LG-PW0545
Terminated
MNIK050060
K051275
Sep 17, 2008Allez Spine, LLC
Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 5 x 40mm, Winged, Catalog # LG-PW0540
Terminated
MNIK050060
K051275
Sep 17, 2008Allez Spine, LLC
Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 5 x 35mm, Winged, Catalog # LG-PW0535
Terminated
MNIK050060
K051275
Sep 17, 2008Allez Spine, LLC
Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 7 x 45mm, Non-winged, Catalog # LG-PR0745
Terminated
MNIK050060
K051275
Sep 17, 2008Allez Spine, LLC
Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 7 x 40mm, Non-winged, Catalog # LG-PR0740
Terminated
MNIK050060
K051275
Sep 17, 2008Allez 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
MNIK050060
K051275
Sep 17, 2008Allez Spine, LLC
Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 6 x 50mm, Non-winged, Catalog # LG-PR0650
Terminated
MNIK050060
K051275
Sep 17, 2008Allez Spine, LLC
Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 6 x 40mm, Non-winged, Catalog # LG-PR0640
Terminated
MNIK050060
K051275
Sep 17, 2008Allez Spine, LLC
Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 6 x 35mm, Non-winged, Catalog # LG-PR0635
Terminated
MNIK050060
K051275
Sep 17, 2008Allez Spine, LLC
Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 6 x 30mm, Non-winged, Catalog # LG-PR0630
Terminated
MNIK050060
K051275
Sep 17, 2008Allez Spine, LLC
Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 5 x 45mm, Non-winged, Catalog # LG-PR0545
Terminated
MNIK050060
K051275
Sep 17, 2008Allez Spine, LLC
Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 5 x 35mm, Non-winged, Catalog # LG-PR0535
Terminated
MNIK050060
K051275
Sep 17, 2008Allez Spine, LLC
Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 5 x 30mm, Non-winged, Catalog # LG-PR0530
Terminated
MNIK050060
K051275
Sep 2, 2008Allez 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
MNIK050060
Sep 1, 2008Abbott 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
MNIK030625
K071174
Sep 1, 2008Abbott 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
MNIK021564
K023644

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