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510(k) K133575

Device
SPINEVISION LUMIS CANNULATED PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. PEDICLE SCREW FIXATION SYSTEM
Applicant
SPINEVISION, S.A.
510(k) number
K133575
Product code
MNH  
Decision
Substantially Equivalent (SESE)
Decision date
2014-06-30
Date received
2013-11-20
Regulation
888.3070
Classification name
Orthosis, Spondylolisthesis Spinal Fixation
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
J.D. WEBB
Address
Antony Parc Ii 10 Pl. Du General De Gaulle Antony Cedex FR 92184 92184

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MNH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC2016-12-02
K162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd.2016-11-03
K162143FixxSure® X-LinkInnovasis, Inc.2016-09-23
K161151Spinal fixation systemCanwell Medical Co., Ltd.2016-09-21
K162189ANAX™ 5.5 Spinal SystemU&I Corporation2016-08-30
K151362HC Spinal SystemHung Chun Bio-S Co., Ltd.2016-05-05
K153404Zavation Spinal SystemZavation, LLC2016-04-21
K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine2016-03-02
K143013Spinal Inner Fixation SystemChangzhou Dingjian Medical Appliance Co., Ltd.2015-12-11
K151695Romeo posterior osteosynthesis systemSpineart2015-09-10
K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine2015-06-26
K150283Republic Spine Dark Star Spinal SystemRepublic Spine, LLC2015-04-29
K142798PASS LP Spinal SystemMedicrea International SA2015-03-25
K143417ANAX 5.5 Spinal SystemU&I Corporation2015-02-25
K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc.2015-02-12

Legacy Summary#

summary

FDA Review#

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