Catalog Number

107-018-7035

Brand Name

NA

Version/Model Number

107-018-7035

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K162232

Product Code

NKB

Product Code Name

Orthosis, spinal pedicle fixation, for degenerative disc disease

Public Device Record Key

a31b4e6d-b008-4265-a300-211f323e7258

Public Version Date

October 19, 2018

Public Version Number

4

DI Record Publish Date

January 10, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-