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FDA 510(k)

Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm

K-Number: K160996 · 2016-07-06

ApplicantDunamis, LLC
Decision Date2016-07-06
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm is a medical device manufactured by Dunamis, LLC. It received FDA 510(k) clearance on 2016-07-06 under approval number K160996. 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 Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm?

Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm is a medical device that received FDA 510(k) clearance on 2016-07-06. It is manufactured by Dunamis, LLC. The 510(k) number is K160996.

When was Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm approved by the FDA?

Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm received FDA 510(k) clearance on 2016-07-06, under approval number K160996.

What company makes Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm?

Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm is manufactured by Dunamis, LLC.

What is the FDA product code for Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm?

The FDA product code for Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm 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)

Other Devices by Dunamis, LLC

K153746Dunamis Force DFX Tensile Tape K191319Dunamis Fixation Button System K193245Dunamis PunchTac Suture Anchors

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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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