Catalog Number

EVO9067401

Brand Name

NEOTIS

Version/Model Number

NEOTIS Plate - Right

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

K140226

Product Code

HRS

Product Code Name

Plate, Fixation, Bone

Public Device Record Key

62f59818-3038-48e7-9f20-c0553c9c3b18

Public Version Date

January 10, 2020

Public Version Number

5

DI Record Publish Date

October 14, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-