Catalog Number

39-PA-5545

Brand Name

Reform Pedicle Screw System

Version/Model Number

39-PA-5545

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

K121172

Product Code

MNH

Product Code Name

Orthosis, Spondylolisthesis Spinal Fixation

Public Device Record Key

b52ae38f-e7ee-4526-ad45-1d7290d633ab

Public Version Date

May 27, 2019

Public Version Number

1

DI Record Publish Date

May 17, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-