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FDA 510(k)

TruShot with Y-Knot All-Suture Anchor

K-Number: K182446 · 2018-12-19

ApplicantConmed Corporation
Decision Date2018-12-19
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TruShot with Y-Knot All-Suture Anchor is a medical device manufactured by Conmed Corporation. It received FDA 510(k) clearance on 2018-12-19 under approval number K182446. 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 TruShot with Y-Knot All-Suture Anchor?

TruShot with Y-Knot All-Suture Anchor is a medical device that received FDA 510(k) clearance on 2018-12-19. It is manufactured by Conmed Corporation. The 510(k) number is K182446.

When was TruShot with Y-Knot All-Suture Anchor approved by the FDA?

TruShot with Y-Knot All-Suture Anchor received FDA 510(k) clearance on 2018-12-19, under approval number K182446.

What company makes TruShot with Y-Knot All-Suture Anchor?

TruShot with Y-Knot All-Suture Anchor is manufactured by Conmed Corporation.

What is the FDA product code for TruShot with Y-Knot All-Suture Anchor?

The FDA product code for TruShot with Y-Knot 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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