BioBrace®
K-Number: K242187 · 2024-11-27
ApplicantConmed Corporation
Decision Date2024-11-27
Product CodeOWW
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
BioBrace® is a medical device manufactured by Conmed Corporation. It received FDA 510(k) clearance on 2024-11-27 under approval number K242187. The device is classified under product code OWW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BioBrace®?
BioBrace® is a medical device that received FDA 510(k) clearance on 2024-11-27. It is manufactured by Conmed Corporation. The 510(k) number is K242187.
When was BioBrace® approved by the FDA?
BioBrace® received FDA 510(k) clearance on 2024-11-27, under approval number K242187.
What company makes BioBrace®?
BioBrace® is manufactured by Conmed Corporation.
What is the FDA product code for BioBrace®?
The FDA product code for BioBrace® is OWW.
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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.