Catalog Number

10-2005-S

Brand Name

S-Core™

Version/Model Number

10-2005-S

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

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

K162171,K162171

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Public Device Record Key

01526624-5a64-47dc-b2ba-660dc62ecf01

Public Version Date

May 09, 2022

Public Version Number

2

DI Record Publish Date

November 15, 2020

Package DI Number

10850017962221

Quantity per Package

10

Contains DI Package

00850017962224

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case