Novel Spinal Spacer System - Novel SD, Self Distracting PEEK Cage, Wide, - ALPHATEC SPINE, INC.

Duns Number:602465783

Device Description: Novel SD, Self Distracting PEEK Cage, Wide, Novel, M, 8 mm

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More Product Details

Catalog Number

-

Brand Name

Novel Spinal Spacer System

Version/Model Number

64835-008

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

K080699

Product Code Details

Product Code

MAX

Product Code Name

Intervertebral fusion device with bone graft, lumbar

Device Record Status

Public Device Record Key

06292013-c529-46b2-9348-cf0d5b1f8567

Public Version Date

February 24, 2020

Public Version Number

4

DI Record Publish Date

August 31, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ALPHATEC SPINE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5644
2 A medical device with a moderate to high risk that requires special controls. 26570
U Unclassified 15