Catalog Number

-

Brand Name

Simpact

Version/Model Number

152-14-950

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

K201538

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Public Device Record Key

0427e244-09e0-4767-8700-602c0835c138

Public Version Date

October 12, 2021

Public Version Number

1

DI Record Publish Date

October 04, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-