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Panels › Orthopedic › Product code MNH · Class 2

Orthosis, Spondylolisthesis Spinal Fixation

Regulation 888.3070

0510(k)s in 12 months (309 all time)
0recalls in 12 months (15 all time)
14recalls that name a 510(k)
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Top companies in MNH

DateFirm and productCodeLinked 510(k)
Apr 27, 2017XTANT MEDICAL INC
5.5mm Diameter x 500mm CoCr Straight Rod, Model number X077-0420. The product is packaged in plastic bags with one piece per bag. Product Usage: The 5.5mm dia. X 500 mm CoCr Straight Rod is an acces
Terminated
MNHK120832
Nov 22, 2016Amendia, Inc
Savannah-T Straight Rod, 200mm, Part Number 10704-200; Savannah-T Straight Rod, 250mm, Part Number 10704-250; Savannah T-Straight Rod 300mm, Part Number 10704-300; Savannah-T Straight Rod, 400mm, Part
Terminated
MNHK132925
K152920 +2
Jul 10, 2015Exactech, Inc.
Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107. Intended to provide immobilization and stabilization of spinal segments.
Terminated
MNHK051216
Jun 22, 2015X Spine Systems Inc
Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone: 937-847-8400
Terminated
MNHK120832
Apr 22, 2015X Spine Systems Inc
Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device for spinal surgery consisting of rods, pedicle screw assemblies (screw, cap, yoke) and cross bar connector assemblies.
Terminated
MNHK120832
Mar 11, 2013Synthes USA HQ, Inc.
Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread Length, Part Number 487.072. Intended to provide precise and segmental stabilization of the spine in skeletally mature pati
Terminated
MNHK992739
Oct 29, 2012Alphatec Spine, Inc.
ILLlCO MIS Posterior Fixation System, Bone-screw Internal Spinal Fixation System, Orthosis, Spinal Pedical Fixation Orthosis, Spondylolisthesis Spinal Fixation The ILLICO MIS Posterior Fixation Sys
Terminated
MNHK042673
K071890
Sep 22, 2009EBI, L.P.
Fixed Closed Screw (Ti); 5.0MM (D) x 25MM (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
MNHK993956
Sep 22, 2009EBI, L.P.
Fixed Open Screw (TI); 7.0MM (D) x 30MM (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 fr
Terminated
MNHK993956
Sep 22, 2009EBI, L.P.
Fixed Closed Screw, 6.5mm (D) x 40mm (L), Made in USA; Biomet Spine, Parsippany, NJ The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures t
Terminated
MNHK993956
Sep 16, 2009Stryker Spine
Stryker Trio Connector Hex Socket for Torque Wrench 3.5MM Not Sterile: Manufactured by: Stryker Spine SAS, Cestas, France; Distributed in the USA by: Stryker Spine, Allendale, NJ 07401 The Trio 3.5MM
Terminated
MNHK032855
K052971 +1
Aug 19, 2009X Spine Systems Inc
Capless Li Pedicle Screw System, Diameters - 4.75mm, 5.5mm, 6.5mm, 7.5mm, 8.25mm, Lengths 30mm-55mm, labeled non-sterile. The Capless LI Pedicle Screw System is indicated for the treatment of sever s
Terminated
MNHK072282
Jul 7, 2009Stryker Spine
Stryker Mantis Rod Inserter Inner Shaft; Non Sterile; Manufactured by Stryker Spine SAS, Cestas France. Distributed by Stryker Spine, Allendale, NJ 07401-1677. The MANTIS Spinal System is intended f
Terminated
MNHK061813
Jul 7, 2009Stryker Spine
Stryker Mantis Rod Inserter; Non Sterile, Manufactured by Stryker Spine SAS, Cestas, France. Distributed by Howmedica Osteonics Corp; 325 Corporate Drive, Mahwah, NJ 07430. The MANTIS Spinal System
Terminated
MNHK061813
Sep 21, 2005Stryker Howmedica Osteonics Corp.
The TRIO Spondylolisthesis Reduction Instrument is a Class I Manual Surgical Instrument unique to the implantation of Stryker Spine TRIO PS this instrument is intended for use in the reduction of dege
Terminated
MNHNone listed

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