PYRAMESH® C Titanium Mesh - MESH X1009459 PYR OVOID TI 13X17X30 - MEDTRONIC SOFAMOR DANEK, INC.

Duns Number:830350380

Device Description: MESH X1009459 PYR OVOID TI 13X17X30

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More Product Details

Catalog Number

-

Brand Name

PYRAMESH® C Titanium Mesh

Version/Model Number

X1009459

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

K011406

Product Code Details

Product Code

MQP

Product Code Name

SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Device Record Status

Public Device Record Key

9b51d958-2c7f-4d12-a355-9585ef34b44e

Public Version Date

February 24, 2020

Public Version Number

4

DI Record Publish Date

September 09, 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