INTER FIX™ Threaded Fusion Device - 20X23MM INTER FIX THREADED - MEDTRONIC SOFAMOR DANEK, INC.

Duns Number:830350380

Device Description: 20X23MM INTER FIX THREADED

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

INTER FIX™ Threaded Fusion Device

Version/Model Number

890-203

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

P000058,P970015

Product Code Details

Product Code

MAX

Product Code Name

Intervertebral fusion device with bone graft, lumbar

Device Record Status

Public Device Record Key

e3565fe1-08f8-4b15-b709-40e26222d505

Public Version Date

February 24, 2020

Public Version Number

4

DI Record Publish Date

December 24, 2014

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