Catalog Number

9022-03

Brand Name

BONE-LOK MVP Cortical-Cancellous Compression Device

Version/Model Number

TMCD-35-2530S

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

-

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Public Device Record Key

ee3873ff-6d3c-42b8-a11d-5748d0ba22aa

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-