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 a medical device manufactured by U&I Corporation. It received FDA 510(k) clearance on 2018-08-09 under approval 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. It is manufactured by U&I Corporation. The 510(k) number is K180759.
When was SECULOK Suture Anchor approved by the FDA?
SECULOK Suture Anchor received FDA 510(k) clearance on 2018-08-09, under approval number K180759.
What company makes SECULOK Suture Anchor?
SECULOK Suture Anchor is manufactured by U&I Corporation.
What is the FDA product code for SECULOK Suture Anchor?
The FDA product code for SECULOK Suture Anchor is MBI.
Related PubMed Literature
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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.