Catalog Number

TRY-PS 45 14-S

Brand Name

TRYPTIK®2 C-Plate Anterior Cervical Plate System

Version/Model Number

TRY-PS 45 14-S

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 06, 2019

Issuing Agency

In GS1

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

-

Product Code

KWQ

Product Code Name

Appliance, Fixation, Spinal Intervertebral Body

Public Device Record Key

78b0329d-6267-4269-8f2e-325ae279a73e

Public Version Date

February 21, 2019

Public Version Number

4

DI Record Publish Date

August 31, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-