Catalog Number

XSD02006

Brand Name

NEXIS

Version/Model Number

XSD02006

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

-

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

0509d45b-0dfc-4e96-ba71-140e7b3c5579

Public Version Date

May 18, 2021

Public Version Number

1

DI Record Publish Date

May 10, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-