ENDOSKELETON® DPK - Disc Prep Kit, Posterior, Down Angled, Cup - TITAN SPINE, LLC

Duns Number:623316978

Device Description: Disc Prep Kit, Posterior, Down Angled, Cup Curette, 8mm

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More Product Details

Catalog Number

1900-0002

Brand Name

ENDOSKELETON® DPK

Version/Model Number

1900-0002

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 18, 2020

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

K083714

Product Code Details

Product Code

MAX

Product Code Name

Intervertebral fusion device with bone graft, lumbar

Device Record Status

Public Device Record Key

0115f3fb-2d96-4b8d-b38a-a35feffde677

Public Version Date

December 09, 2020

Public Version Number

4

DI Record Publish Date

September 30, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TITAN SPINE, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 243
2 A medical device with a moderate to high risk that requires special controls. 5255