Catalog Number

3051-0130

Brand Name

ENDOSKELETON® TC

Version/Model Number

3051-0130

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

-

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

K100889

Product Code

ODP

Product Code Name

Intervertebral fusion device with bone graft, cervical

Public Device Record Key

e7edb2bb-4434-4c6e-bd05-b10fac1613b0

Public Version Date

September 16, 2022

Public Version Number

6

DI Record Publish Date

November 01, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-