SCARLET® AL-T Intervertebral body fusion device - Secured Lumbar Anterior Cage - SpineArt SA

Duns Number:483016148

Device Description: Secured Lumbar Anterior Cage

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More Product Details

Catalog Number

SCA-LM 15 13-S

Brand Name

SCARLET® AL-T Intervertebral body fusion device

Version/Model Number

SCA-LM 15 13-S

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

-

Product Code Details

Product Code

MAX

Product Code Name

Intervertebral Fusion Device With Bone Graft, Lumbar

Device Record Status

Public Device Record Key

5988e347-9534-4fa5-9f32-37dfdd5e72ab

Public Version Date

February 24, 2020

Public Version Number

2

DI Record Publish Date

December 07, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SPINEART SA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 974
2 A medical device with a moderate to high risk that requires special controls. 5209