LumFix spinal fixation system

GUDID 08809658605566

Regulation Name : Pedicle screw spinal system

CG Bio Co., Ltd.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile
Primary Device ID08809658605566
NIH Device Record Key2357238e-cf97-4603-8f40-bb220ea1fbb3
Commercial Distribution StatusIn Commercial Distribution
Brand NameLumFix spinal fixation system
Version Model NumberRDPS5030
Company DUNS631130655
Company NameCG Bio Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809658605566 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNIOrthosis, Spinal Pedicle Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809658605566]

Moist Heat or Steam Sterilization


[08809658605566]

Moist Heat or Steam Sterilization


[08809658605566]

Moist Heat or Steam Sterilization


[08809658605566]

Moist Heat or Steam Sterilization


[08809658605566]

Moist Heat or Steam Sterilization


[08809658605566]

Moist Heat or Steam Sterilization


[08809658605566]

Moist Heat or Steam Sterilization


[08809658605566]

Moist Heat or Steam Sterilization


[08809658605566]

Moist Heat or Steam Sterilization


[08809658605566]

Moist Heat or Steam Sterilization


[08809658605566]

Moist Heat or Steam Sterilization


[08809658605566]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-04
Device Publish Date2020-07-27

On-Brand Devices [LumFix spinal fixation system]

08809658602039Regulation Name: Pedicle screw spinal system
08809658602022Regulation Name: Pedicle screw spinal system
08809658602015Regulation Name: Pedicle screw spinal system
08809658602008Regulation Name: Pedicle screw spinal system
08809658601995Regulation Name: Pedicle screw spinal system
08809658601988Regulation Name: Pedicle screw spinal system
08809658601971Regulation Name: Pedicle screw spinal system
08809658601964Regulation Name: Pedicle screw spinal system
08809658601957Regulation Name: Pedicle screw spinal system
08809658601940Regulation Name: Pedicle screw spinal system
08809658601933Regulation Name: Pedicle screw spinal system
08809658601926Regulation Name: Pedicle screw spinal system
08809658601919Regulation Name: Pedicel screw spinal system
08809658601902Regulation Name: Pedicel screw spinal system
08809658601896Regulation Name: Pedicle screw spinal system
08809658601889Regulation Name: Pedcile screw spinal system
08809658601872Regulation Name: Pedicle screw spinal system
08809658601865Regulation Name: Pedicle screw spinal system
08809658601858Regulation Name: Pedicle screw spinal system
08809658601841Regulation Name: Pedicle screw spinal system
08809658601834Regulation Name: Pedicle screw spinal system
08809658601827Regulation Name: Pedicle screw spinal system
08809658601810Regulation Name: Pedicle screw spinal system
08809658601803Regulation Name: Pedicle screw spinal system
08809550978461Regulation Name: Pedicle screw spinal system
08809429619099Regulation Name: Pedicle screw spinal system
08809429618757Regulation Name: Pedicle screw spinal system
08809429618740Regulation Name: Pedicle screw spinal system
08809429618733Regulation Name: Pedicle screw spinal system
08809429614872Regulation Name: Pedicle screw spinal system
08809429614841Regulation Name: Pedicle screw spinal system
08809429614834Regulation Name: Pedicle screw spinal system
08809429611130Regulation Name: Pedicle screw spinal system
08809429611031Regulation Name: Pedicle screw spinal system
08809429611024Regulation Name: Pedicle screw spinal system
08809429611017Regulation Name: Pedicle screw spinal system
08809429610904Regulation Name: Pedicle screw spinal system
08809304757007Regulation Name: Pedicle screw spinal system
08809304756994Regulation Name: Pedicle screw spinal system
08809304756987Regulation Name: Pedicle screw spinal system
08809429619341Regulation Name: Pedicle screw spinal system
08809429619334Regulation Name: Pedicle screw spinal system
08809429619327Regulation Name: Pedicle screw spinal system
08809429619310Regulation Name: Pedicle screw spinal system
08809429619303Regulation Name: Pedicle screw spinal system
08809429619242Regulation Name: Pedicle screw spinal system
08809429619235Regulation Name: Pedicle screw spinal system
08809429619228Regulation Name: Pedicle screw spinal system
08809429619211Regulation Name: Pedicle screw spinal system
08809429619204Regulation Name: Pedicle screw spinal system

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