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FDA 510(k)

BioBrace ® RC Delivery System

K-Number: K250395 · 2025-04-07

ApplicantConmed Corporation
Decision Date2025-04-07
Product CodeORQ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BioBrace ® RC Delivery System is a medical device manufactured by Conmed Corporation. It received FDA 510(k) clearance on 2025-04-07 under approval number K250395. The device is classified under product code ORQ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BioBrace ® RC Delivery System?

BioBrace ® RC Delivery System is a medical device that received FDA 510(k) clearance on 2025-04-07. It is manufactured by Conmed Corporation. The 510(k) number is K250395.

When was BioBrace ® RC Delivery System approved by the FDA?

BioBrace ® RC Delivery System received FDA 510(k) clearance on 2025-04-07, under approval number K250395.

What company makes BioBrace ® RC Delivery System?

BioBrace ® RC Delivery System is manufactured by Conmed Corporation.

What is the FDA product code for BioBrace ® RC Delivery System?

The FDA product code for BioBrace ® RC Delivery System is ORQ.

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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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