ENDOSKELETON® TAS nanoLOCK® Surface Technology - Interbody Fusion Device 7 Degree X-Large 11mm - MEDTRONIC SOFAMOR DANEK, INC.

Duns Number:830350380

Device Description: Interbody Fusion Device 7 Degree X-Large 11mm

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More Product Details

Catalog Number

-

Brand Name

ENDOSKELETON® TAS nanoLOCK® Surface Technology

Version/Model Number

2307-0311-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

K141953,K173535,K183557,K192018

Product Code Details

Product Code

OVD

Product Code Name

Intervertebral fusion device with integrated fixation, lumbar

Device Record Status

Public Device Record Key

b95bac29-9cab-431a-ac6a-1c9249c85ee4

Public Version Date

April 07, 2021

Public Version Number

7

DI Record Publish Date

December 15, 2016

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