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FDA 510(k)

BioBrace® Extra-Articular Ligament Augmentation Kit

K-Number: K252946 · 2025-10-15

ApplicantConmed Corporation
Decision Date2025-10-15
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BioBrace® Extra-Articular Ligament Augmentation Kit is a medical device manufactured by Conmed Corporation. It received FDA 510(k) clearance on 2025-10-15 under approval number K252946. 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 BioBrace® Extra-Articular Ligament Augmentation Kit?

BioBrace® Extra-Articular Ligament Augmentation Kit is a medical device that received FDA 510(k) clearance on 2025-10-15. It is manufactured by Conmed Corporation. The 510(k) number is K252946.

When was BioBrace® Extra-Articular Ligament Augmentation Kit approved by the FDA?

BioBrace® Extra-Articular Ligament Augmentation Kit received FDA 510(k) clearance on 2025-10-15, under approval number K252946.

What company makes BioBrace® Extra-Articular Ligament Augmentation Kit?

BioBrace® Extra-Articular Ligament Augmentation Kit is manufactured by Conmed Corporation.

What is the FDA product code for BioBrace® Extra-Articular Ligament Augmentation Kit?

The FDA product code for BioBrace® Extra-Articular Ligament Augmentation Kit is MAI.

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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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