ClearanceBrief
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

Company510(k)sRecalls
Valorem Surgical LLC0144
Allez Spine, LLC127
Medtronic Sofamor Danek250
K2m, Inc.150
Spine Wave, Inc.110
Blackstone Medical, Inc.73
Stryker Spine72
Spinal USA80
Spinal Solutions, LLC08
Life Spine70
DateFirm and productCodeLinked 510(k)
Mar 11, 2008Allez Spine, LLC
Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 80, Catalog Number LG-PR0880, Allez Spine, LLC., Irvine, CA
Terminated		 MNIK050060
Mar 11, 2008Allez Spine, LLC
Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 55, Catalog Number LG-PR0855, Allez Spine, LLC., Irvine, CA
Terminated		 MNIK050060
Mar 11, 2008Allez Spine, LLC
Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 50, Catalog Number LG-PR0850, Allez Spine, LLC., Irvine, CA
Terminated		 MNIK050060
Mar 11, 2008Allez Spine, LLC
Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 45, Catalog Number LG-PR0845, Allez Spine, LLC., Irvine, CA
Terminated		 MNIK050060
Mar 11, 2008Allez Spine, LLC
Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 40, Catalog Number LG-PR0840, Allez Spine, LLC., Irvine, CA
Terminated		 MNIK050060
Mar 11, 2008Allez Spine, LLC
Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 35, Catalog Number LG-PR0835, Allez Spine, LLC., Irvine, CA
Terminated		 MNIK050060
Dec 11, 2007Blackstone Medical, Inc.
Ascent POCTS (Posterior Occipital Cervical Thoracic System) Part Numbers: 65-33 XX Series (65-3310,-3312, -3314, -3318, -3320-, -3322, -3324, -3326, -3328, and -3330), Multi-Axial Screw, 4.0mm x 26mm;
Terminated		 MNINone listed
Feb 8, 2007Medtronic Sofamor Danek Instrument Manufacturing
Rocker Reducer, part of the SiLo Spinal System, REF 8880014, Rx only, Material: Stainless Steel, qty: 1 ea, non-sterile, Medtronic Sofamor Danek, 1800 Pyramid Place Memphis, TN 38132, USA, Manufact
Terminated		 MNIK042210
Sep 8, 2004U&I America
Optima Spinal System and Spinal Hook System, set screw component.
Terminated		 MNIK020279
K024096 +2
Feb 27, 2004U&I America
4mm Hex Driver
Terminated		 MNIK020279
K024096 +2
Feb 27, 2004U&I America
2.5mm Hex Driver
Terminated		 MNIK020279
K024096 +2
Aug 27, 2003U&I America
Optima Large Poly Screw Driver
Terminated		 MNIK031585
Aug 27, 2003U&I America
Optima Poly Screw Driver.
Terminated		 MNIK020279
K031585

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