Fixed-Angle Reduction Screw

GUDID 06912547300519

Shandong Weigao Orthopaedic Device Co., Ltd.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID06912547300519
NIH Device Record Key448ad128-92cf-4705-ba0d-65f81554803b
Commercial Distribution Discontinuation2017-08-28
Commercial Distribution StatusNot in Commercial Distribution
Brand NameFixed-Angle Reduction Screw
Version Model Number8248565
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
GS106912547300519 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNHOrthosis, Spondylolisthesis Spinal Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06912547300519]

Moist Heat or Steam Sterilization


[06912547300519]

Moist Heat or Steam Sterilization


[06912547300519]

Moist Heat or Steam Sterilization


[06912547300519]

Moist Heat or Steam Sterilization


[06912547300519]

Moist Heat or Steam Sterilization


[06912547300519]

Moist Heat or Steam Sterilization


[06912547300519]

Moist Heat or Steam Sterilization


[06912547300519]

Moist Heat or Steam Sterilization


[06912547300519]

Moist Heat or Steam Sterilization


[06912547300519]

Moist Heat or Steam Sterilization


[06912547300519]

Moist Heat or Steam Sterilization


[06912547300519]

Moist Heat or Steam Sterilization


[06912547300519]

Moist Heat or Steam Sterilization


[06912547300519]

Moist Heat or Steam Sterilization


[06912547300519]

Moist Heat or Steam Sterilization


[06912547300519]

Moist Heat or Steam Sterilization


[06912547300519]

Moist Heat or Steam Sterilization


[06912547300519]

Moist Heat or Steam Sterilization


[06912547300519]

Moist Heat or Steam Sterilization


[06912547300519]

Moist Heat or Steam Sterilization


[06912547300519]

Moist Heat or Steam Sterilization


[06912547300519]

Moist Heat or Steam Sterilization


[06912547300519]

Moist Heat or Steam Sterilization


[06912547300519]

Moist Heat or Steam Sterilization


[06912547300519]

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 Reduction Screw]

069394883320898247565
069394883320728247560
069394883320658247555
069394883320588247550
069394883320418247545
069394883320348247540
069394883320278247535
069394883320108247530
069394883320038247525
069394883319908247065
069394883319838247060
069394883319768247055
069394883319698247050
069394883319528247045
069394883319458247040
069394883319388247035
069394883319218247030
069394883319148247025
069394883319078246565
069394883318918246560
069394883318848246555
069394883318778246550
069394883318608246545
069394883318538246540
069394883318468246535
069394883318398246530
069394883318228246525
069394883318158246065
069394883318088246060
069394883317928246055
069394883317858246050
069394883317788246045
069394883317618246040
069394883317548246035
069394883317478246030
069394883317308246025
069394883317238245555
069394883317168245550
069394883317098245545
069394883316938245540
069394883316868245535
069394883316798245530
069394883316628245525
069394883316558245055
069394883316488245050
069394883316318245045
069394883316248245040
069394883316178245035
069394883316008245030
069394883315948245025

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