CASSIOPEIA Cervical Plate System 3320-0024

GUDID 08806395494347

The CASSIOPEIA 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 Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable
Primary Device ID08806395494347
NIH Device Record Key022bb9fd-d588-41d5-b7f7-7963640eb1fe
Commercial Distribution StatusIn Commercial Distribution
Brand NameCASSIOPEIA Cervical Plate System
Version Model Number3320-0024
Catalog Number3320-0024
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

Device Identifiers

Device Issuing AgencyDevice ID
GS108806395494347 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806395494347]

Moist Heat or Steam Sterilization

[08806395494347]

Moist Heat or Steam Sterilization

[08806395494347]

Moist Heat or Steam Sterilization

[08806395494347]

Moist Heat or Steam Sterilization

[08806395494347]

Moist Heat or Steam Sterilization

[08806395494347]

Moist Heat or Steam Sterilization

[08806395494347]

Moist Heat or Steam Sterilization

[08806395494347]

Moist Heat or Steam Sterilization

[08806395494347]

Moist Heat or Steam Sterilization

[08806395494347]

Moist Heat or Steam Sterilization

[08806395494347]

Moist Heat or Steam Sterilization

[08806395494347]

Moist Heat or Steam Sterilization

[08806395494347]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2023-09-18
Device Publish Date2019-06-18

On-Brand Devices [CASSIOPEIA Cervical Plate System]

08809885720025The CASSIOPEIA Cervical Plate System is a multiple component system that comprises several sizes
08809885709778The CASSIOPEIA Cervical Plate System is a multiple component system that comprises several sizes
08800104099960The CASSIOPEIA Cervical Plate System is a multiple component system that comprises several sizes
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08809885733902The CASSIOPEIA Cervical Plate System is a multiple component system that comprises several sizes
08809885733896The CASSIOPEIA Cervical Plate System is a multiple component system that comprises several sizes
08809885733889The CASSIOPEIA Cervical Plate System is a multiple component system that comprises several sizes
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08809885733612The CASSIOPEIA Cervical Plate System is a multiple component system that comprises several sizes
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08809885733599The CASSIOPEIA Cervical Plate System is a multiple component system that comprises several sizes
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08806395494651The CASSIOPEIA Cervical Plate System is a multiple component system that comprises several sizes
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08806395494637The CASSIOPEIA Cervical Plate System is a multiple component system that comprises several sizes
08806395494620The CASSIOPEIA Cervical Plate System is a multiple component system that comprises several sizes
08806395494613The CASSIOPEIA Cervical Plate System is a multiple component system that comprises several sizes
08806395494606The CASSIOPEIA Cervical Plate System is a multiple component system that comprises several sizes
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