Lateral Connector5.5

GUDID 06912547142669

Shandong Weigao Orthopaedic Device Co., Ltd.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID06912547142669
NIH Device Record Key2a03b0ee-b54e-4e3e-9dc9-302c8959b97a
Commercial Distribution StatusIn Commercial Distribution
Brand NameLateral Connector5.5
Version Model Number8426005
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
GS106912547142669 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNHOrthosis, Spondylolisthesis Spinal Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06912547142669]

Moist Heat or Steam Sterilization


[06912547142669]

Moist Heat or Steam Sterilization


[06912547142669]

Moist Heat or Steam Sterilization


[06912547142669]

Moist Heat or Steam Sterilization


[06912547142669]

Moist Heat or Steam Sterilization


[06912547142669]

Moist Heat or Steam Sterilization


[06912547142669]

Moist Heat or Steam Sterilization


[06912547142669]

Moist Heat or Steam Sterilization


[06912547142669]

Moist Heat or Steam Sterilization


[06912547142669]

Moist Heat or Steam Sterilization


[06912547142669]

Moist Heat or Steam Sterilization


[06912547142669]

Moist Heat or Steam Sterilization


[06912547142669]

Moist Heat or Steam Sterilization


[06912547142669]

Moist Heat or Steam Sterilization


[06912547142669]

Moist Heat or Steam Sterilization


[06912547142669]

Moist Heat or Steam Sterilization


[06912547142669]

Moist Heat or Steam Sterilization


[06912547142669]

Moist Heat or Steam Sterilization


[06912547142669]

Moist Heat or Steam Sterilization


[06912547142669]

Moist Heat or Steam Sterilization


[06912547142669]

Moist Heat or Steam Sterilization


[06912547142669]

Moist Heat or Steam Sterilization


[06912547142669]

Moist Heat or Steam Sterilization


[06912547142669]

Moist Heat or Steam Sterilization


[06912547142669]

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

Devices Manufactured by Shandong Weigao Orthopaedic Device Co., Ltd.

06912547086260 - Multi-Axial Screw2018-07-06
06912547086284 - Multi-Axial Reduction Screw2018-07-06
06912547086307 - Fixed-Angle Screw2018-07-06
06912547086321 - Fixed-Angle Reduction Screw2018-07-06
06912547086345 - Planar Screw2018-07-06
06912547134787 - Planar Screw2018-07-06
06912547134794 - Planar Screw2018-07-06
06912547134800 - Planar Screw2018-07-06

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