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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

Company510(k)sRecalls
Medtronic Sofamor Danek360
Synthes (USA) Products LLC015
Synthes USA (HQ), Inc.012
Globus Medical, Inc.110
Interpore Cross Intl.100
Spine Wave, Inc.100
Depuyacromed80
Ebi, L.P.62
Implex Corp.80
K2m80
Decided510(k)Device and applicantCode
Dec 18, 2007K072537CREASPINE SUPSTANCE VERTEBRAL BODY REPLACEMENT SYSTEM
Creaspine Sas
MQP
Dec 5, 2007K073125VALEO VBR
Amedica Corp.
MQP
Oct 23, 2007K071726ZUMA
Seaspine, Inc.
MQP
Oct 15, 2007K072029PHENIX VERTEBRAL BODY REPLACEMENT
New Business Development, LLC
MQP
Oct 4, 2007K072465NIKO CORPECTOMY SPACER
Globus Medical, Inc.
MQP
Sep 27, 2007K063637RELIANCE VBS SYSTEM
Reliance Medical Systems, LLC
MQP
Aug 31, 2007K070754TRABECULAR METAL VERTEBRAL BODY REPLACEMENT (VBR), MODEL# 06-115, 06-155
Zimmer Trabecular Metal Technology
MQP
Aug 30, 2007K072132LDR SPINE ROI-T SYSTEM
Ldr Spine USA
MQP
Aug 24, 2007K071274GSO GS1 SPACER
Gold Standard Orthopedics, LLC
MQP
Aug 14, 2007K071033T2 XVBR SPINAL SYSTEM
Medtronic Sofamor Danek
MQP
Jul 30, 2007K071031VU E*POD VERTEBRAL BODY REPLACEMENT
Theken Spine, LLC
MQP
Jun 29, 2007K071497ATLAS SPINE VERTEBRAL BODY REPLACEMENT
Atlas Spine, Inc.
MQP
Jun 28, 2007K070786X-POD ADJUSTABLE VERTEBRAL BODY REPLACEMENT
Theken Spine, LLC
MQP
Jun 25, 2007K063393SMALL STATURE SPACERS
Biomet Spine
MQP
Jun 11, 2007K071372MODIFICATION TO: INTERPLATE VBR SYSTEM
Rsb Spine, LLC
MQP
May 30, 2007K070382VISTA -S DEVICE
Zimmer Trabecular Metal Technology
MQP
Apr 25, 2007K070381THEKEN VU MESH VBR SYSTEM
Theken Spine, LLC
MQP
Apr 20, 2007K070082XY COR SPINAL IMPLANT FOR MINIMAL INVASIVE SPINAL SURGERY
Vertebration,Inc
MQP
Apr 19, 2007K070316INTERPLATE VBR SYSTEM
Rsb Spine, LLC
MQP
Apr 18, 2007K070181SINTEA BIOTECH DSC/ALF SPINAL SYSTEM, DSC.XX.T5.XX, ALF.XX.T5.XX
Sintea Biotech, Inc.
MQP
Apr 6, 2007K070218VERTIFLEX OCTANE PEEK VERTEBRAL BODY REPLACEMENT (PEEK VBR)
Vertiflex (Tm), Incorporated
MQP
Apr 3, 2007K062083SYNFIX -LR
Synthes Spine Co.Lp
MQP
Mar 14, 2007K070173VERTE-STACK SPINAL SYSTEM
Medtronic Sofamor Danek, Inc.
MQP
Mar 9, 2007K063464ATLAS SPINE VERTEBRAL BODY REPLACEMENT
Atlas Spine, Inc.
MQP
Mar 5, 2007K063491T2 SCEPTOR SPINAL SYSTEM
Medtronic Sofamor Danek
MQP
Feb 26, 2007K063205ATLAS SPINE VERTEBRAL BODY REPLACEMENT
Atlas Spine, LLC
MQP
Feb 23, 2007K063399ALEUTIAN SPACER SYSTEM
K2m, Inc.
MQP
Jan 31, 2007K062933SYNTHES ORACLE SPACER
Synthes Spine Co.Lp
MQP
Jan 25, 2007K062666VUSION TS, PS, AND CS PARTIAL VERTEBRAL BODY REPLACEMENTS
Ortho Development Corp.
MQP
Jan 12, 2007K062759PARAMOUNT VBR SYSTEM
Innovative Spinal Technologies, Inc.
MQP
Dec 26, 2006K061578SSP VERTEBRAL BODY REPLACEMENT
Specialty Spine Products, LLC
MQP
Dec 26, 2006K060416OBELISC VERTEBRAL BODY REPLACEMENT DEVICE
Ulrich GmbH & Co. KG
MQP
Dec 22, 2006K062151BOX PEEK VBR SYSTEM
Innovasis, Inc.
MQP
Dec 18, 2006K061082MOBIS SPINAL IMPLANT
Signus Medizintechnik GmbH
MQP
Oct 17, 2006K062810SOLITAIRE ANTERIOR SPINAL SYSTEM
Ebi, L.P.
MQP
Sep 26, 2006K062133MODIFICATION TO VERTE-STACK SPINAL SYSTEM
Medtronic Spinal and Biologics Div
MQP
Sep 22, 2006K061155VISTA P VERTEBRAL BODY REPLACEMENT SYSTEM
Zimmer Trabecular
MQP
Sep 14, 2006K060762AESCULAP PEEK VERTEBRAL BODY REPLACEMENT SYSTEM
Aesculap, Inc.
MQP
Sep 12, 2006K062427VERTE-STACK SPINAL SYSTEM
Medtronic Sofamor Danek
MQP
Aug 18, 2006K061891SYNEX II
Synthes Spine Co.Lp
MQP
Aug 18, 2006K061401INTERPLATE VBR SYSTEM
Rsb Spine, LLC
MQP
Aug 16, 2006K062132AVS PL PEEK SPACER SYSTEM
Stryker Spine
MQP
Aug 15, 2006K062004MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT
Quantum Orthopedics, Inc.
MQP
Aug 15, 2006K061752SPINAL USA VBR SYSTEM
Spinal USA
MQP
Aug 14, 2006K062073VERTE-STACK SPINAL SYSTEM
Medtronic Sofamor Danek
MQP
Aug 9, 2006K061938VERTE-STACK SPINAL SYSTEM
Medtronic Sofamor Danek, Inc.
MQP
Aug 3, 2006K061836AVS ASL PEEK SPACER SYSTEM
Stryker Spine
MQP
Jul 24, 2006K061151PIONEER VERTEBRAL SPACER (VERTEBRAL SPACER)
Pioneer Surgical Technology
MQP
Jul 3, 2006K061576MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT SYSTEM
Quantum Orthopedics, Inc.
MQP
Jun 8, 2006K061380RETAIN RADIOLUCENT SPACER
Globus Medical, Inc.
MQP

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