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FDA 510(k)

Q-FIX ULTRA All-Suture Anchor

K-Number: K232457 · 2023-09-08

ApplicantSmith & Nephew
Decision Date2023-09-08
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Q-FIX ULTRA All-Suture Anchor is a medical device manufactured by Smith & Nephew. It received FDA 510(k) clearance on 2023-09-08 under approval number K232457. 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 Q-FIX ULTRA All-Suture Anchor?

Q-FIX ULTRA All-Suture Anchor is a medical device that received FDA 510(k) clearance on 2023-09-08. It is manufactured by Smith & Nephew. The 510(k) number is K232457.

When was Q-FIX ULTRA All-Suture Anchor approved by the FDA?

Q-FIX ULTRA All-Suture Anchor received FDA 510(k) clearance on 2023-09-08, under approval number K232457.

What company makes Q-FIX ULTRA All-Suture Anchor?

Q-FIX ULTRA All-Suture Anchor is manufactured by Smith & Nephew.

What is the FDA product code for Q-FIX ULTRA All-Suture Anchor?

The FDA product code for Q-FIX ULTRA All-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

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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