GMA 2.0 Pedicle Screw System - PRE-BENT ROD, ø5.5 X 170 - GRAFTON MEDICAL ALLIANCE, INC.

Duns Number:063381119

Device Description: PRE-BENT ROD, ø5.5 X 170

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More Product Details

Catalog Number

101-0170-N

Brand Name

GMA 2.0 Pedicle Screw System

Version/Model Number

101-0170-N

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K133063,K192915

Product Code Details

Product Code

MNH

Product Code Name

Orthosis, Spondylolisthesis Spinal Fixation

Device Record Status

Public Device Record Key

c89eb771-4982-4e3e-99a6-dd4d0cf97b3a

Public Version Date

January 17, 2020

Public Version Number

2

DI Record Publish Date

April 25, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GRAFTON MEDICAL ALLIANCE, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 43