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510(k) K111362

Device
REXIOUS SPINAL FIXATION SYSTEM
Applicant
DIO MEDICAL CO., LTD.
510(k) number
K111362
Product code
MNH  
Decision
Substantially Equivalent (SESE)
Decision date
2011-07-21
Date received
2011-05-16
Regulation
888.3070
Classification name
Orthosis, Spondylolisthesis Spinal Fixation
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
APRIL LEE
Address
325 N. Puente St., Unit B Brea CA US 92821 92821

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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