FDA 510(k)

Bonecam Suture Anchor

K-Number: K193108 · 2020-03-26

Decision Date2020-03-26

Product CodeMBI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Bonecam Suture Anchor is a medical device manufactured by Valeris Medical, Inc.. It received FDA 510(k) clearance on 2020-03-26 under approval number K193108. 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 Bonecam Suture Anchor?

Bonecam Suture Anchor is a medical device that received FDA 510(k) clearance on 2020-03-26. It is manufactured by Valeris Medical, Inc.. The 510(k) number is K193108.

When was Bonecam Suture Anchor approved by the FDA?

Bonecam Suture Anchor received FDA 510(k) clearance on 2020-03-26, under approval number K193108.

What company makes Bonecam Suture Anchor?

Bonecam Suture Anchor is manufactured by Valeris Medical, Inc..

What is the FDA product code for Bonecam Suture Anchor?

The FDA product code for Bonecam Suture Anchor is MBI.

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

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