Catalog Number

B-ASC-4550

Brand Name

ActivaScrew™

Version/Model Number

B-ASC-4550

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K081392

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Public Device Record Key

01c341f4-d499-4fde-9139-eb72ac5214c8

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 27, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-