Catalog Number

SC080055

Brand Name

NEXIS

Version/Model Number

SC080055

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

K143229

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Public Device Record Key

c5bd40ce-4461-4ed8-8f34-d9c76e2eae22

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 29, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-