Catalog Number

CC-004-04

Brand Name

Orthros

Version/Model Number

Ø4.5mm Polyaxial Pedicle Screw, 40mm Lg.

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

-

Product Code

NKB

Product Code Name

Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease

Public Device Record Key

509aa088-2dd6-471b-a362-eb4d81da934d

Public Version Date

February 05, 2020

Public Version Number

3

DI Record Publish Date

October 26, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-