LT-CAGE® Lumbar Tapered Fusion Device - CAGE 8941623 LT CAGE 16X19 5X23 - MEDTRONIC SOFAMOR DANEK, INC.

Duns Number:830350380

Device Description: CAGE 8941623 LT CAGE 16X19 5X23

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More Product Details

Catalog Number

-

Brand Name

LT-CAGE® Lumbar Tapered Fusion Device

Version/Model Number

8941623

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

677551f1-c663-47d4-bb6f-aa7ad35f9091

Public Version Date

February 24, 2020

Public Version Number

4

DI Record Publish Date

September 23, 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