Catalog Number

RFS-S4540

Brand Name

RFS™ Screw

Version/Model Number

RFS-S4540

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2017

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

5aceebd7-227a-4dc0-b613-d33c8c9a142b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-