TSRH® Spinal System - ROD 8370030 TSR2D PCUT BENT 30MMX5.5MM - MEDTRONIC SOFAMOR DANEK, INC.

Duns Number:830350380

Device Description: ROD 8370030 TSR2D PCUT BENT 30MMX5.5MM

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More Product Details

Catalog Number

-

Brand Name

TSRH® Spinal System

Version/Model Number

8370030

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

K010720

Product Code Details

Product Code

KWP

Product Code Name

APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Device Record Status

Public Device Record Key

687cbebf-67c1-4ac0-ab1d-60f040fd996b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 05, 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