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FDA 510(k)

Apollo Knotless Suture Anchor

K-Number: K230123 · 2023-05-03

ApplicantMaruho Medical
Decision Date2023-05-03
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Apollo Knotless Suture Anchor is a medical device manufactured by Maruho Medical. It received FDA 510(k) clearance on 2023-05-03 under approval number K230123. 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 Apollo Knotless Suture Anchor?

Apollo Knotless Suture Anchor is a medical device that received FDA 510(k) clearance on 2023-05-03. It is manufactured by Maruho Medical. The 510(k) number is K230123.

When was Apollo Knotless Suture Anchor approved by the FDA?

Apollo Knotless Suture Anchor received FDA 510(k) clearance on 2023-05-03, under approval number K230123.

What company makes Apollo Knotless Suture Anchor?

Apollo Knotless Suture Anchor is manufactured by Maruho Medical.

What is the FDA product code for Apollo Knotless Suture Anchor?

The FDA product code for Apollo Knotless Suture Anchor is MBI.

Related Clinical Trials

NCT04552119 Safety of Treatment of Shoulder Repair COMPLETED NCT07491276 Efficacy of Using Knotless Barbed Suture vs N-Butyl Cyanoacrylate Glue Tissue Adhesive for Closure of Intraoral Surgical Incisions ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 40868376 Correlation Analysis of Suture Anchor Pull-Out Strength with Cortical Bone Thickness and Cancellous Bone Density on a Finite Element Model. Bioengineering (Basel, Switzerland) (2025)

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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.

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