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510(k) K953369

Device
STAINLESS STEEL VARIFIX SYSTEM 5.0MM DIAMETER ANCHOR SCREW
Applicant
ADVANCED SPINE FIXATION SYSTEMS, INC.
510(k) number
K953369
Product code
MNH  
Decision
Substantially Equivalent For Some Indications (SN)
Decision date
1995-09-08
Date received
1995-07-18
Regulation
888.3070
Classification name
Orthosis, Spondylolisthesis Spinal Fixation
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JAMES A RINNER
Address
11095 Knott Ave. Suite L Cypress CA US 90630 90630

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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#

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FDA Review#

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