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FDA 510(k)

SECULOK™ Suture Anchor

K-Number: K180759 · 2018-08-09

ApplicantU&I Corporation
Decision Date2018-08-09
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SECULOK™ Suture Anchor is the device name listed in this FDA 510(k) record. The listed applicant is U&I Corporation. It received FDA 510(k) clearance on 2018-08-09 under 510(k) number K180759. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SECULOK™ Suture Anchor?

SECULOK™ Suture Anchor is a medical device that received FDA 510(k) clearance on 2018-08-09. The listed applicant is U&I Corporation. The 510(k) number is K180759.

When did SECULOK™ Suture Anchor receive FDA 510(k) clearance?

SECULOK™ Suture Anchor received FDA 510(k) clearance on 2018-08-09, under 510(k) number K180759.

Who is the listed applicant for SECULOK™ Suture Anchor?

The FDA 510(k) record lists U&I Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SECULOK™ Suture Anchor?

The FDA product code for SECULOK™ Suture Anchor is MBI.

Other records listing U&I Corporation as applicant

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Related Devices (Code: MBI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker EndoscopyK261770Suture Button Repair SystemSkeletal Dynamics, Inc.K261632Thunderbolt SystemResponsive Arthroscopy, Inc.K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)Smith & Nephew, Inc.K260018Arthrex FiberButtonArthrex, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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