Catalog Number

C2ST16102

Brand Name

Innovasis® Cranial System

Version/Model Number

C2ST16102

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K141644

Product Code

GWO

Product Code Name

Plate, Cranioplasty, Preformed, Alterable

Public Device Record Key

4c2bc011-a501-4b85-b952-e96ac6ae545e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 29, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-