Catalog Number

XT001106-1

Brand Name

TC-100

Version/Model Number

XT001106-1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 17, 2022

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

K993106

Product Code

HRS

Product Code Name

Plate, fixation, bone

Public Device Record Key

36dd65a0-4e11-40ba-adba-1046bfa0e2e4

Public Version Date

March 18, 2022

Public Version Number

3

DI Record Publish Date

May 03, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-