FDA 510(k)

BioBrace ® RC Delivery System

K-Number: K250395 · 2025-04-07

Decision Date2025-04-07

Product CodeORQ

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

BioBrace ® RC Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Conmed Corporation. It received FDA 510(k) clearance on 2025-04-07 under 510(k) 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. The listed applicant is Conmed Corporation. The 510(k) number is K250395.

When did BioBrace ® RC Delivery System receive FDA 510(k) clearance?

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

Who is the listed applicant for BioBrace ® RC Delivery System?

The FDA 510(k) record lists Conmed Corporation as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Conmed Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.