Catalog Number

-

Brand Name

STERISPINE PS

Version/Model Number

KITM535

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K112453

Product Code

NKB

Product Code Name

Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease

Public Device Record Key

d09aeac7-d9e4-455e-af9c-d32b95880d90

Public Version Date

April 07, 2020

Public Version Number

4

DI Record Publish Date

October 31, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-