Catalog Number

4200-1046

Brand Name

ENDOSKELETON TT

Version/Model Number

4200-1046

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 03, 2017

Issuing Agency

In HIBCC

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

K083714

Product Code

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Public Device Record Key

8e284f4f-eabc-4e94-b32a-72fa21f9ccdd

Public Version Date

September 16, 2022

Public Version Number

8

DI Record Publish Date

December 08, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-