MVP Cervical Plate System 3300-4075

GUDID 08806395496471

The MVP Cervical Plate System is a multiple component system that comprises several sizes of plates and screws and associated manual surgical instruments. The MVP Cervical Plate System implants are supplied non-sterile, are single use, and are fabricated from medical grade titanium alloy (Ti6Al4V ELI, ASTM F 136) The MVP Cervical Plate System is intended for anterior cervical fixation (C2-C7) in skeletally mature patients as an adjunct to fusion for the following indications: Degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), Spondylolisthesis, Trauma (including fracture or dislocation), Spinal stenosis, Deformities or curvatures (kyphosis, lordosis, or scoliosis), Tumors, Pseudoarthrosis and Failed previous fusion.

GS Medical Co., Ltd.

Spinal fixation plate, non-bioabsorbable
Primary Device ID08806395496471
NIH Device Record Key3a215c2f-a4f6-4aec-b548-630ab90d269c
Commercial Distribution StatusIn Commercial Distribution
Brand NameMVP Cervical Plate System
Version Model Number3300-4075
Catalog Number3300-4075
Company DUNS688385418
Company NameGS Medical Co., Ltd.
Device Count1
DM Exempttrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108806395496471 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806395496471]

Moist Heat or Steam Sterilization

[08806395496471]

Moist Heat or Steam Sterilization

[08806395496471]

Moist Heat or Steam Sterilization

[08806395496471]

Moist Heat or Steam Sterilization

[08806395496471]

Moist Heat or Steam Sterilization

[08806395496471]

Moist Heat or Steam Sterilization

[08806395496471]

Moist Heat or Steam Sterilization

[08806395496471]

Moist Heat or Steam Sterilization

[08806395496471]

Moist Heat or Steam Sterilization

[08806395496471]

Moist Heat or Steam Sterilization

[08806395496471]

Moist Heat or Steam Sterilization

[08806395496471]

Moist Heat or Steam Sterilization

[08806395496471]

Moist Heat or Steam Sterilization

[08806395496471]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-07-02
Device Publish Date2019-06-18

On-Brand Devices [MVP Cervical Plate System]

08806395497195The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
08806395497188The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
08806395497171The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
08806395497164The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
08806395497157The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
08806395497140The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
08806395497133The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
08806395497126The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
08806395497119The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
08806395497102The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
08806395497096The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
08806395497089The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
08806395497072The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
08806395497065The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
08806395497058The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
08806395497041The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
08806395497034The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
08806395497027The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
08806395497010The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
08806395497003The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
08806395496990The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
08806395496983The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
08806395496976The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
08806395496969The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
08806395496952The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
08806395496945The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
08806395496938The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
08806395496921The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
08806395496914The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
08806395496907The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
08806395496891The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
08806395496884The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
08806395496877The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
08806395496860The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
08806395496853The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
08806395496846The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
08806395496839The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
08806395496822The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
08806395496815The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
08806395496808The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
08806395496792The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
08806395496785The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
08806395496778The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
08806395496761The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
08806395496754The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
08806395496747The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
08806395496730The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
08806395496723The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
08806395496716The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
08806395496709The MVP Cervical Plate System is a multiple component system that comprises several sizes of pla
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