Cyclops Anterior Cervical Plate System - Screw, Self Tapping, 4.6, Variable - DEGEN MEDICAL, INC.

Duns Number:078812602

Device Description: Screw, Self Tapping, 4.6, Variable

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More Product Details

Catalog Number

0224-4517V

Brand Name

Cyclops Anterior Cervical Plate System

Version/Model Number

0224-4517V

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K191786

Product Code Details

Product Code

KWQ

Product Code Name

Appliance, fixation, spinal intervertebral body

Device Record Status

Public Device Record Key

c231fa10-2416-494c-b17c-5f3694e0a45a

Public Version Date

September 20, 2019

Public Version Number

1

DI Record Publish Date

September 12, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DEGEN MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 511
2 A medical device with a moderate to high risk that requires special controls. 4143