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)
Top companies in MQP
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Sofamor Danek | 36 | 0 |
| Synthes (USA) Products LLC | 0 | 15 |
| Synthes USA (HQ), Inc. | 0 | 12 |
| Globus Medical, Inc. | 11 | 0 |
| Interpore Cross Intl. | 10 | 0 |
| Spine Wave, Inc. | 10 | 0 |
| Depuyacromed | 8 | 0 |
| Ebi, L.P. | 6 | 2 |
| Implex Corp. | 8 | 0 |
| K2m | 8 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 20, 2022 | NuVasive Inc X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixation. Open, Classified |
MQP | K090176 |
| Sep 21, 2020 | Synthes (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 |
MQP | K041389 |
| Sep 21, 2020 | Synthes (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 |
MQP | K003275 K983766 |
| Sep 21, 2020 | Synthes (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 |
MQP | K003275 K983766 |
| Sep 21, 2020 | Synthes (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 |
MQP | K003275 K983766 |
| Sep 21, 2020 | Synthes (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 |
MQP | K003275 K983766 |
| Sep 21, 2020 | Synthes (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 |
MQP | K003275 K983766 |
| Sep 21, 2020 | Synthes (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 |
MQP | K003275 K983766 |
| Sep 21, 2020 | Synthes (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 |
MQP | K003275 K983766 |
| Sep 21, 2020 | Synthes (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 |
MQP | K003275 K983766 |
| Sep 21, 2020 | Synthes (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 |
MQP | K003275 K983766 |
| Sep 21, 2020 | Synthes (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 |
MQP | K003275 K983766 |
| Sep 21, 2020 | Synthes (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 |
MQP | K003275 K983766 |
| Sep 21, 2020 | Synthes (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 |
MQP | K003275 K983766 |
| Sep 21, 2020 | Synthes (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 |
MQP | K003275 K983766 |
| Sep 21, 2020 | Synthes (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 |
MQP | K003275 K983766 |
| Mar 17, 2017 | Eden Spine Europe SA GIZA Vertebral Body Replacement Terminated |
MQP | K112429 |
| Jun 2, 2014 | Synthes, 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 |
MQP | K103320 |
| Jul 26, 2013 | Atlas Spine, Inc. Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000
Used to rotate implant into position Terminated |
MQP | K063205 K091406 |
| Dec 17, 2012 | TITAN 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 |
MQP | K032812 |
| Sep 11, 2012 | Lucero 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 |
MQP | K093207 |
| Feb 17, 2012 | Lucero 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 |
MQP | None listed |
| May 19, 2011 | Integra 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 |
MQP | K032064 |
| Mar 2, 2011 | Integra 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 |
MQP | K080822 |
| Jul 23, 2010 | Synthes 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 |
MQP | K053508 |
| Jan 15, 2010 | Orthofix, 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 |
MQP | K081849 |
| Nov 9, 2009 | Synthes 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 |
MQP | K003836 |
| Nov 9, 2009 | Synthes 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 |
MQP | K003836 |
| Nov 9, 2009 | Synthes 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 |
MQP | K003836 |
| Nov 9, 2009 | Synthes 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 |
MQP | K003836 |
| Nov 9, 2009 | Synthes 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 |
MQP | K003836 |
| Nov 9, 2009 | Synthes 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 |
MQP | K003836 |
| Nov 9, 2009 | Synthes 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 |
MQP | K003836 |
| Nov 9, 2009 | Synthes 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 |
MQP | K003836 |
| Nov 9, 2009 | Synthes 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 |
MQP | K003836 |
| Nov 9, 2009 | Synthes 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 |
MQP | K003836 |
| Nov 9, 2009 | Synthes 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 |
MQP | K003836 |
| Sep 22, 2009 | EBI, 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 |
MQP | K993956 |
| Sep 22, 2009 | EBI, 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 |
MQP | K993956 |
| Dec 31, 2008 | Alphatec 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 |
MQP | K050553 |
| Dec 31, 2008 | Alphatec 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 |
MQP | None listed |
| Jan 17, 2007 | Abbott Spine TraXis Fixed Rasp in sizes: 7mm, 9mm, 11mm, 13mm and 15mm; for use with TraXis vertebral body replacement system Terminated |
MQP | None listed |
| Jan 17, 2007 | Abbott Spine TraXis Fixed Trial in sizes: 7mm, 9mm, 11mm, 13mm and 15mm; part of TraXis vertebral body replacement system Terminated |
MQP | None listed |
| Feb 7, 2006 | Abbott Spine TraXis Vue Spinal Implant System, Part #2601-090921 Terminated |
MQP | K031855 |
| Feb 4, 2005 | Interpore Cross International Inc Spinal Implant,
Catalog number: 1000-3000 through 1000-3015 (9 catalog numbers) Terminated |
MQP | K040168 |
| Aug 14, 2004 | Spinal 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 |
MQP | K033517 |
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