Zenius Spinal System - Cannulated Poly-Axial Screw 7.5mm x 65mm, 5.5mm - Medyssey Co., Ltd.

Duns Number:688211503

Device Description: Cannulated Poly-Axial Screw 7.5mm x 65mm, 5.5mm Rod, Long Reduction Type

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More Product Details

Catalog Number

-

Brand Name

Zenius Spinal System

Version/Model Number

ZXCP7565

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

MNH

Product Code Name

Orthosis, Spondylolisthesis Spinal Fixation

Device Record Status

Public Device Record Key

8762398c-31cf-4055-9e91-d7ff00a2d8ce

Public Version Date

August 06, 2018

Public Version Number

1

DI Record Publish Date

July 04, 2018

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