Catalog Number

73-1302

Brand Name

STERNALOCK® BLU SYSTEM

Version/Model Number

73-1302

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 27, 2020

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

K111908

Product Code

HRS

Product Code Name

PLATE, FIXATION, BONE

Public Device Record Key

1c705921-2492-47ee-8d4b-7125783826c1

Public Version Date

July 08, 2021

Public Version Number

7

DI Record Publish Date

October 11, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-