Catalog Number

EVO9067722

Brand Name

OTIS-C PLUS

Version/Model Number

OTIS-C PLUS Plate - Left

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 09, 2020

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

HRS

Product Code Name

Plate, Fixation, Bone

Public Device Record Key

1e215d24-1f34-496f-89c3-5a638c8b18c5

Public Version Date

January 10, 2020

Public Version Number

4

DI Record Publish Date

October 16, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-