Catalog Number

ACL-4101

Brand Name

Inion Hexalon™ ACL/PCL Screw

Version/Model Number

1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

August 25, 2025

Issuing Agency

In HIBCC

MRI safety Status

MR Safe

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

K071464

Product Code

HWC

Product Code Name

Screw, fixation, bone

Public Device Record Key

33cb5de2-9ea8-4d73-9e2f-aa0235c64859

Public Version Date

August 29, 2022

Public Version Number

5

DI Record Publish Date

February 07, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-