Catalog Number

110025990

Brand Name

Ventix® Link Knotless Anchor

Version/Model Number

110025990

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K180274

Product Code

MBI

Product Code Name

Fastener, Fixation, Nondegradable, Soft Tissue

Public Device Record Key

cb4af6fe-9d16-4e1c-9cda-0ae66260aeda

Public Version Date

October 21, 2021

Public Version Number

2

DI Record Publish Date

September 21, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-