Catalog Number

EVONS66036

Brand Name

OTIS-C PLUS

Version/Model Number

NON STERILE Screw for OTIS-C PLUS plate fixation

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 19, 2015

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

K120818

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Public Device Record Key

e1c5921c-e8b9-4d2d-b737-7b702fc32227

Public Version Date

October 31, 2019

Public Version Number

4

DI Record Publish Date

October 19, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-