Catalog Number

OM-8500

Brand Name

SPEEDSCREW

Version/Model Number

OM-8500

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"

Yes

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

K101448

Product Code

HWC

Product Code Name

Screw, fixation, bone

Public Device Record Key

70295ad8-d2c4-4bed-873a-b960cf43738c

Public Version Date

October 09, 2020

Public Version Number

6

DI Record Publish Date

November 13, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-