Catalog Number

-

Brand Name

OS2®-C

Version/Model Number

T30 SP110

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

K153395

Product Code

JDR

Product Code Name

Staple, Fixation, Bone

Public Device Record Key

5075569e-71a6-4f22-a8f1-12925e05f0a8

Public Version Date

November 23, 2021

Public Version Number

4

DI Record Publish Date

March 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-