Catalog Number

86-0013

Brand Name

Shoreline™ ACS

Version/Model Number

86-0013

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 19, 2022

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

K183083

Product Code

ODP

Product Code Name

Intervertebral fusion device with bone graft, cervical

Public Device Record Key

701b7304-deaa-4f19-b519-f1640f3dc6e4

Public Version Date

April 19, 2022

Public Version Number

2

DI Record Publish Date

August 20, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-