Catalog Number

PSS08-4540

Brand Name

Polyaxial screw, w/o cannulation, 4.5mm/40mm

Version/Model Number

PSS08-4540

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"

Yes

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

-

Product Code

NKB

Product Code Name

Orthosis, spinal pedicle fixation, for degenerative disc disease

Public Device Record Key

351e467d-77bc-481b-b734-afb43e6da701

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 06, 2016

Package DI Number

EMAHPSS0845401

Quantity per Package

1

Contains DI Package

EMAHPSS0845400

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-