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Panels › Orthopedic › Product code MQP · Class 2

Spinal Vertebral Body Replacement Device

Regulation 888.3060

3510(k)s in 12 months (279 all time)
0recalls in 12 months (46 all time)
42recalls that name a 510(k)
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Top companies in MQP

DateFirm and productCodeLinked 510(k)
Dec 20, 2022NuVasive Inc
X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixation.
Open, Classified
MQPK090176
Sep 21, 2020Synthes (USA) Products LLC
3.0MM LOCKING SCREW LOW PROFILE (TI) Product Number: 495-491 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprin
Terminated
MQPK041389
Sep 21, 2020Synthes (USA) Products LLC
STANDARD RING 22MM X 28MM (TI) Product Number: 495-406 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and
Terminated
MQPK003275
K983766
Sep 21, 2020Synthes (USA) Products LLC
STANDARD RING 17MM X 22MM (TI) Product Number: 495-405 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and
Terminated
MQPK003275
K983766
Sep 21, 2020Synthes (USA) Products LLC
END RING 22MM X 28MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495-398 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in v
Terminated
MQPK003275
K983766
Sep 21, 2020Synthes (USA) Products LLC
END RING 22MM X 28MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495-396 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in v
Terminated
MQPK003275
K983766
Sep 21, 2020Synthes (USA) Products LLC
END RING 17MM X 22MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495.394 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in v
Terminated
MQPK003275
K983766
Sep 21, 2020Synthes (USA) Products LLC
END RING 17MM X 22MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495.392 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in v
Terminated
MQPK003275
K983766
Sep 21, 2020Synthes (USA) Products LLC
END RING 15MM DIA/0 DEG (TI) Product Number: 495.386 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and h
Terminated
MQPK003275
K983766
Sep 21, 2020Synthes (USA) Products LLC
END RING 12MM DIA/0 DEG (TI) Product Number: 495.385 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and h
Terminated
MQPK003275
K983766
Sep 21, 2020Synthes (USA) Products LLC
END RING 10MM DIA/0 DEG (TI) Product Number: 495.384 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and h
Terminated
MQPK003275
K983766
Sep 21, 2020Synthes (USA) Products LLC
SYNMESH 22MM X 28MM 88MM HEIGHT (TI) Product Number: 495.379 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprin
Terminated
MQPK003275
K983766
Sep 21, 2020Synthes (USA) Products LLC
SYNMESH 17MM X 22MM 88MM HEIGHT (TI) Product Number: 495-374 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprin
Terminated
MQPK003275
K983766
Sep 21, 2020Synthes (USA) Products LLC
SYNMESH 15MM DIA 88MM HEIGHT (TI) Product Number: 495.366 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints
Terminated
MQPK003275
K983766
Sep 21, 2020Synthes (USA) Products LLC
SYNMESH 12MM DIA 88MM HEIGHT (TI) Product Number: 495.357 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints
Terminated
MQPK003275
K983766
Sep 21, 2020Synthes (USA) Products LLC
DePuy Synthes SYNMESH 10MM DIA 18MM HEIGHT (TI) Product Number: 495.344 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in variou
Terminated
MQPK003275
K983766
Mar 17, 2017Eden Spine Europe SA
GIZA Vertebral Body Replacement
Terminated
MQPK112429
Jun 2, 2014Synthes, Inc.
Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL System, a vertebral body replacement device. For spinal surgery. The Synthes XRL device is intended to be used
Terminated
MQPK103320
Jul 26, 2013Atlas Spine, Inc.
Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position
Terminated
MQPK063205
K091406
Dec 17, 2012TITAN SPINE, LLC
Titan Spine Endoskeleton TA Implant products. 2107-0118 18mm Standard Endoskeleton Implant VBR 2107-0120 20mm Standard Endoskeleton Implant VBR 2107-0218 18mm Large Endoskeleton Implant VBR 2107-02
Terminated
MQPK032812
Sep 11, 2012Lucero Medical LLC
Enduramesh Corpectomy Spacer System Product Usage: The Enduramesh is a vertebral body replacement system intended for use in the thoracic and lumbar spine (T1-S1) to replace a collapsed, damaged or u
Terminated
MQPK093207
Feb 17, 2012Lucero Medical LLC
ENDURAMESH CORPECTOMY SPACER SYSTEM 013MM, 017MM, 023MM by varying heights. Dist. By: Lucero Medical, PO Box 67, Richfield, Ohio 44826 Product Usage: Device Description: The Enduramesh is a vertebra
Terminated
MQPNone listed
May 19, 2011Integra LifeSciences Corp.
Theken L"POD" Titanium Vertebral Body Replacement System, Vu c"POD" PEEK-Optima Vertebral Body Replacement System, c"POD" Titanium Vertebral Body Replacement System The Theken CPOD / LPOD VBR is indi
Terminated
MQPK032064
Mar 2, 2011Integra LifeSciences Corp.
Vu a-POD Intervertebral Body Fusion Device. Packaged as surgical kits containing all implants and instruments required for a procedure. Also packaged as individual instruments and implants in poly b
Terminated
MQPK080822
Jul 23, 2010Synthes USA (HQ), Inc.
SynFix-LR Spinal Implant System (Implant Holder for SynFix-LR and surgical technique brochure) The implant holder is used to place the implant into the vertebral disc space.
Terminated
MQPK053508
Jan 15, 2010Orthofix, Inc
Orthofix Spinal Implants; Pillar SA PEEK Spacer System Instrument Case. Case contents: Implant Insertion Instrument, Straight Tamp, Bone Awl Drill Guide, Straight Drill, U-Joint Driver with and withou
Terminated
MQPK081849
Nov 9, 2009Synthes USA (HQ), Inc.
Synthes USA, TI Synex (TM) II Central Body 97mm - 123mm, Catalog number 04.808.011. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due
Terminated
MQPK003836
Nov 9, 2009Synthes USA (HQ), Inc.
Synthes USA, TI Synex (TM) II Central Body 84mm - 110mm, Catalog number 04.808.010. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due
Terminated
MQPK003836
Nov 9, 2009Synthes USA (HQ), Inc.
Synthes USA, TI Synex (TM) II Central Body 71mm - 97mm, Catalog number 04.808.009. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due
Terminated
MQPK003836
Nov 9, 2009Synthes USA (HQ), Inc.
Synthes USA, TI Synex (TM) II Central Body 58mm - 84mm, Catalog number 04.808.008. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due
Terminated
MQPK003836
Nov 9, 2009Synthes USA (HQ), Inc.
Synthes USA, TI Synex (TM) II Central Body 45mm - 71mm, Catalog number 04.808.007. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due
Terminated
MQPK003836
Nov 9, 2009Synthes USA (HQ), Inc.
Synthes USA, TI Synex (TM) II Central Body 37mm - 52mm, Catalog number 04.808.006. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due
Terminated
MQPK003836
Nov 9, 2009Synthes USA (HQ), Inc.
Synthes USA, TI Synex (TM) II Central Body 29mm - 44mm, Catalog number 04.808.005. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due
Terminated
MQPK003836
Nov 9, 2009Synthes USA (HQ), Inc.
Synthes USA, TI Synex (TM) II Central Body 25mm - 33mm, Catalog number 04.808.004. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due
Terminated
MQPK003836
Nov 9, 2009Synthes USA (HQ), Inc.
Synthes USA, TI Synex (TM) II Central Body 21mm - 29mm, Catalog number 04.808.003. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due
Terminated
MQPK003836
Nov 9, 2009Synthes USA (HQ), Inc.
Synthes USA, TI Synex (TM) II Central Body 17mm - 25mm, Catalog number 04.808.002. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due
Terminated
MQPK003836
Nov 9, 2009Synthes USA (HQ), Inc.
Synthes USA, TI Synex (TM) II Central Body 14mm - 19mm, Catalog number 04.808.001. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due
Terminated
MQPK003836
Sep 22, 2009EBI, L.P.
Bone Screw 7MM (D) x 35 MM (L) Telescopic Plate Spacer Thoracolumbar Spinal System; Made in USA Biomet Spine, Parsippany, NJ 07054 The screw devices are an internal fixation device intended to aid in
Terminated
MQPK993956
Sep 22, 2009EBI, L.P.
Bone Screw 6MM (D) x 35MM (L) Telescopic Plate Spacer, Thoracolumbar Spinal System Made in USA, Biomet Spine, Parsippany, NJ 07054 The screw devices are an internal fixation device intended to aid in
Terminated
MQPK993956
Dec 31, 2008Alphatec Spine, Inc.
Novel PEEK VBR XS 16-22 MM, S-5, 26MM, Part Numbers : 64753-126. Indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged or unstable vertebra
Terminated
MQPK050553
Dec 31, 2008Alphatec Spine, Inc.
Novel PEEK VBR XS 16-22 MM, S-5, 20MM, Part Number: 64733-120. Indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged or unstable vertebra
Terminated
MQPNone listed
Jan 17, 2007Abbott Spine
TraXis Fixed Rasp in sizes: 7mm, 9mm, 11mm, 13mm and 15mm; for use with TraXis vertebral body replacement system
Terminated
MQPNone listed
Jan 17, 2007Abbott Spine
TraXis Fixed Trial in sizes: 7mm, 9mm, 11mm, 13mm and 15mm; part of TraXis vertebral body replacement system
Terminated
MQPNone listed
Feb 7, 2006Abbott Spine
TraXis Vue Spinal Implant System, Part #2601-090921
Terminated
MQPK031855
Feb 4, 2005Interpore Cross International Inc
Spinal Implant, Catalog number: 1000-3000 through 1000-3015 (9 catalog numbers)
Terminated
MQPK040168
Aug 14, 2004Spinal Concepts, Inc
Harmony MIS Life Instruments, Lumbar Spacer Systems manufactured by Spinal Concepts, Austin, Texas. Part numbers 2851-1-01, 2851-1-30, 2851-2-01, 2851-2-30, 2851-3-01, 2851-3-30, 2851-4-01, 2851-4-30
Terminated
MQPK033517

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