Catalog Number

-

Brand Name

SECULOK™ Suture Anchor

Version/Model Number

PAS5503

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

K180759

Product Code

MBI

Product Code Name

Fastener, fixation, nondegradable, soft tissue

Public Device Record Key

666b9bcb-50f9-406e-ace3-6a2534e04e74

Public Version Date

March 21, 2019

Public Version Number

3

DI Record Publish Date

August 15, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-