Fixed-Angle Screw

GUDID 06912547300205

Shandong Weigao Orthopaedic Device Co., Ltd.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID06912547300205
NIH Device Record Key6fbb5394-0a1c-4335-9d46-8e768d502262
Commercial Distribution Discontinuation2017-08-28
Commercial Distribution StatusNot in Commercial Distribution
Brand NameFixed-Angle Screw
Version Model Number8238045
Company DUNS545249039
Company NameShandong Weigao Orthopaedic Device 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 Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106912547300205 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNHOrthosis, Spondylolisthesis Spinal Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06912547300205]

Moist Heat or Steam Sterilization


[06912547300205]

Moist Heat or Steam Sterilization


[06912547300205]

Moist Heat or Steam Sterilization


[06912547300205]

Moist Heat or Steam Sterilization


[06912547300205]

Moist Heat or Steam Sterilization


[06912547300205]

Moist Heat or Steam Sterilization


[06912547300205]

Moist Heat or Steam Sterilization


[06912547300205]

Moist Heat or Steam Sterilization


[06912547300205]

Moist Heat or Steam Sterilization


[06912547300205]

Moist Heat or Steam Sterilization


[06912547300205]

Moist Heat or Steam Sterilization


[06912547300205]

Moist Heat or Steam Sterilization


[06912547300205]

Moist Heat or Steam Sterilization


[06912547300205]

Moist Heat or Steam Sterilization


[06912547300205]

Moist Heat or Steam Sterilization


[06912547300205]

Moist Heat or Steam Sterilization


[06912547300205]

Moist Heat or Steam Sterilization


[06912547300205]

Moist Heat or Steam Sterilization


[06912547300205]

Moist Heat or Steam Sterilization


[06912547300205]

Moist Heat or Steam Sterilization


[06912547300205]

Moist Heat or Steam Sterilization


[06912547300205]

Moist Heat or Steam Sterilization


[06912547300205]

Moist Heat or Steam Sterilization


[06912547300205]

Moist Heat or Steam Sterilization


[06912547300205]

Moist Heat or Steam Sterilization


[06912547300205]

Moist Heat or Steam Sterilization


[06912547300205]

Moist Heat or Steam Sterilization


[06912547300205]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-07-15

On-Brand Devices [Fixed-Angle Screw]

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069394883960298237560
069394883960128237555
069394883960058237550
069394883959928237545
069394883959858237540
069394883959788237535
069394883959618237530
069394883959548237525
069394883959478237065
069394883959308237060
069394883959238237055
069394883959168237050
069394883959098237045
069394883958938237040
069394883958868237035
069394883958798237030
069394883958628237025
069394883958558236565
069394883958488236560
069394883958318236555
069394883958248236550
069394883958178236545
069394883958008236540
069394883957948236535
069394883957878236530
069394883957708236525
069394883957638236065
069394883957568236060
069394883957498236055
069394883957328236050
069394883957258236045
069394883957188236040
069394883957018236035
069394883956958236030
069394883956888236025
069394883956718235555
069394883956648235550
069394883956578235545
069394883956408235540
069394883956338235535
069394883956268235530
069394883956198235525
069394883956028235055
069394883955968235050
069394883955898235045
069394883955728235040
069394883955658235035
069394883955588235030
069394883955418235025

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