TIGER SHARK Spinal System - TigerShark,Inserter, Angled,Left - Choice Spine, LP

Duns Number:078293017

Device Description: TigerShark,Inserter, Angled,Left

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More Product Details

Catalog Number

-

Brand Name

TIGER SHARK Spinal System

Version/Model Number

V070-1003L

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

-

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

K172816

Product Code Details

Product Code

MAX

Product Code Name

Intervertebral fusion device with bone graft, lumbar

Device Record Status

Public Device Record Key

df31bfee-35c3-436f-8096-68508f0edea4

Public Version Date

June 28, 2019

Public Version Number

1

DI Record Publish Date

June 20, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CHOICE SPINE, LP" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2373
2 A medical device with a moderate to high risk that requires special controls. 5754
U Unclassified 61