A Link Z - A Link Z Ti Unitary FRA Interbody 27x17 12° - ACUITY SURGICAL DEVICES, LLC

Duns Number:025855111

Device Description: A Link Z Ti Unitary FRA Interbody 27x17 12°

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

A Link Z

Version/Model Number

14-27271712

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

K201671

Product Code Details

Product Code

OVD

Product Code Name

Intervertebral Fusion Device With Integrated Fixation, Lumbar

Device Record Status

Public Device Record Key

a36bb927-15b9-4fdd-9daf-6680f028c5de

Public Version Date

December 13, 2021

Public Version Number

1

DI Record Publish Date

December 03, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ACUITY SURGICAL DEVICES, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 87