Catalog Number

-

Brand Name

OrthoCircle Spine Pedicle Screw System

Version/Model Number

SSC1.011

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

-

Product Code

NKB

Product Code Name

Thoracolumbosacral Pedicle Screw System

Public Device Record Key

c8204035-2d2d-494b-9e59-cc60e254e8c0

Public Version Date

April 06, 2020

Public Version Number

1

DI Record Publish Date

March 29, 2020

Package DI Number

10810005111246

Quantity per Package

5

Contains DI Package

00810005111249

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box