CD HORIZON® Spinal System - SCREW 54740108535 4.75 HA MAS 8.5X35 CC - MEDTRONIC SOFAMOR DANEK, INC.

Duns Number:830350380

Device Description: SCREW 54740108535 4.75 HA MAS 8.5X35 CC

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More Product Details

Catalog Number

-

Brand Name

CD HORIZON® Spinal System

Version/Model Number

54740108535

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

K112555

Product Code Details

Product Code

KWP

Product Code Name

APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Device Record Status

Public Device Record Key

85af3c1b-d820-4a63-bb66-1dee638c7f0e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 10, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDTRONIC SOFAMOR DANEK, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 13352
2 A medical device with a moderate to high risk that requires special controls. 26085
3 A medical device with high risk that requires premarket approval 190
U Unclassified 75