Blustone Synergy Cervical Interbody Fusion System (Slate) - The Blustone Synergy Slate System is a cervical - BLUSTONE SYNERGY, LLC

Duns Number:033467608

Device Description: The Blustone Synergy Slate System is a cervical interbody fusion system comprised of paral The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel and 6° lordotic cages in two footprints with varying heights designed to accommodate patient anatomy, and may be implanted as a single device via an anterior approach.

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More Product Details

Catalog Number

-

Brand Name

Blustone Synergy Cervical Interbody Fusion System (Slate)

Version/Model Number

1713-CL05

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

K171893

Product Code Details

Product Code

ODP

Product Code Name

Intervertebral Fusion Device With Bone Graft, Cervical

Device Record Status

Public Device Record Key

fe844c07-71a0-461b-939a-47d17fbbc853

Public Version Date

February 24, 2020

Public Version Number

4

DI Record Publish Date

January 29, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BLUSTONE SYNERGY, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 76
2 A medical device with a moderate to high risk that requires special controls. 64