Catalog Number

-

Brand Name

Anteralign Spinal System with Titan nanoLock Surface technology

Version/Model Number

4680005

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

-

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

K212524

Product Code

MAX

Product Code Name

Intervertebral fusion device with bone graft, lumbar

Public Device Record Key

145c1772-a96d-4e52-bc23-8e1d8a5c8b6d

Public Version Date

January 03, 2022

Public Version Number

1

DI Record Publish Date

December 26, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-