Aurora Spine - ECHO SD Lumbar Interbody Fusion System, 28mm x - AURORA SPINE, INC.

Duns Number:079119091

Device Description: ECHO SD Lumbar Interbody Fusion System, 28mm x 8mm x 8 degrees x 12mm, UNCOATED

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More Product Details

Catalog Number

112-02808-0812-UC

Brand Name

Aurora Spine

Version/Model Number

ECHO SD

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K133967

Product Code Details

Product Code

MAX

Product Code Name

Intervertebral Fusion Device With Bone Graft, Lumbar

Device Record Status

Public Device Record Key

cec84106-a1a7-46ea-b7e7-6a47b5b77d47

Public Version Date

April 09, 2019

Public Version Number

1

DI Record Publish Date

April 01, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AURORA SPINE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 119
2 A medical device with a moderate to high risk that requires special controls. 2430