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FDA 510(k)

BioBrace®

K-Number: K242187 · 2024-11-27

ApplicantConmed Corporation
Decision Date2024-11-27
Product CodeOWW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BioBrace® is the device name listed in this FDA 510(k) record. The listed applicant is Conmed Corporation. It received FDA 510(k) clearance on 2024-11-27 under 510(k) 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. The listed applicant is Conmed Corporation. The 510(k) number is K242187.

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

BioBrace® received FDA 510(k) clearance on 2024-11-27, under 510(k) number K242187.

Who is the listed applicant for BioBrace®?

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®?

The FDA product code for BioBrace® is OWW.

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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Related Devices (Code: OWW)

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.

K251655VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1)Alafair BiosciencesK250021RotiumNanofiber Solutions, LLCK241906BioBrace® Reinforced ImplantConmed CorporationK240817VersaWrapAlafair Biosciences, Inc.K222220SpinMedix Absorbable Fibrous MembraneCelestray Biotech Company, LLC.,K230316FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences

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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