Catalog Number

AB-2200

Brand Name

Constrictor - Syndesmosis Knotless Adjustable Button System

Version/Model Number

AB-2200

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

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

K191319

Product Code

HTN

Product Code Name

Washer, Bolt Nut

Public Device Record Key

a40bfa3c-41f3-4558-a783-3a19c784c2ab

Public Version Date

May 12, 2021

Public Version Number

2

DI Record Publish Date

April 22, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-