Catalog Number

99-945540

Brand Name

Xcaliber Bone Screws

Version/Model Number

1

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

K955848

Product Code

JDW

Product Code Name

Pin, Fixation, Threaded

Public Device Record Key

e4f0a38a-9a11-4378-bf2c-dfe5fdbc39b6

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 22, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-