Catalog Number

SP 4035-16-2

Brand Name

NA

Version/Model Number

SP 4035-16-2

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

K182818

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Public Device Record Key

a04f8bc5-661a-45d9-9c3f-0fd0b3f14bd6

Public Version Date

April 03, 2020

Public Version Number

1

DI Record Publish Date

March 26, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-