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FDA 510(k)

X-Twist Biocomposite Suture Anchor

K-Number: K232513 · 2023-09-18

ApplicantParcus Medical
Decision Date2023-09-18
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

X-Twist Biocomposite Suture Anchor is a medical device manufactured by Parcus Medical. It received FDA 510(k) clearance on 2023-09-18 under approval number K232513. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the X-Twist Biocomposite Suture Anchor?

X-Twist Biocomposite Suture Anchor is a medical device that received FDA 510(k) clearance on 2023-09-18. It is manufactured by Parcus Medical. The 510(k) number is K232513.

When was X-Twist Biocomposite Suture Anchor approved by the FDA?

X-Twist Biocomposite Suture Anchor received FDA 510(k) clearance on 2023-09-18, under approval number K232513.

What company makes X-Twist Biocomposite Suture Anchor?

X-Twist Biocomposite Suture Anchor is manufactured by Parcus Medical.

What is the FDA product code for X-Twist Biocomposite Suture Anchor?

The FDA product code for X-Twist Biocomposite Suture Anchor is MAI.

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 Parcus Medical

K170877Parcus SLiK Fix Screw K170327Parcus SLiK 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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