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CASSIOPEIA Cervical Plate System

FDA UDI

Class II (US FDA UDI)

by GS Medical Co., Ltd.

Identity

Trade Name
CASSIOPEIA Cervical Plate System FDA UDI
Generic Name
Spinal fixation plate, non-bioabsorbable FDA UDI
Device Name
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. FDA UDI
Model / Reference
3300-2034 FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
3300-2034 FDA UDI
Primary DI / UDI-DI
08806395495856 FDA UDI
510(k) Number
K190170 FDA UDI
FDA Product Code
KWQ FDA UDI
GMDN Term
Spinal fixation plate, non-bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3060 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Spinal fixation plate, non-bioabsorbable

CASSIOPEIA Cervical Plate System by GS Medical Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal fixation plate, non-bioabsorbable.

Cleared under the same submission

K190170 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
GS Medical Co., Ltd.

Sources (1)

  • FDA UDI 4b445aa6-bebf-4be4-91b8-934e813c591f 36 fields · synced Jun 1, 2026