Catalog Number

5210-1067

Brand Name

ENDOSKELETON® TCS

Version/Model Number

5210-1067

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

K142940

Product Code

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Public Device Record Key

5f0798cc-c6a4-40e1-b595-67f69a500db4

Public Version Date

December 09, 2020

Public Version Number

7

DI Record Publish Date

February 16, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-