Catalog Number

53-4216

Brand Name

Spinous Process System

Version/Model Number

53-4216

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

-

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

K121924

Product Code

PEK

Product Code Name

Spinous process plate

Public Device Record Key

3e090bc6-f3a7-44df-b584-596b5d2ce001

Public Version Date

April 23, 2019

Public Version Number

4

DI Record Publish Date

December 17, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-