C7 Cage - Anterior Cervical Fusion Cage, 12mm AP, 14mm ML, - Medyssey Co., Ltd.

Duns Number:688211503

Device Description: Anterior Cervical Fusion Cage, 12mm AP, 14mm ML, 8mm Height

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More Product Details

Catalog Number

-

Brand Name

C7 Cage

Version/Model Number

CL0812

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

ODP

Product Code Name

Intervertebral Fusion Device With Bone Graft, Cervical

Device Record Status

Public Device Record Key

35cea9d7-683d-4971-8d64-20c9b8d2c8ae

Public Version Date

February 24, 2020

Public Version Number

3

DI Record Publish Date

August 19, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDYSSEY CO., LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 10756