Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BioBrace® Reinforced Implant

K-Number: K241906 · 2024-07-29

ApplicantConmed Corporation
Decision Date2024-07-29
Product CodeOWW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BioBrace® Reinforced Implant is the device name listed in this FDA 510(k) record. The listed applicant is Conmed Corporation. It received FDA 510(k) clearance on 2024-07-29 under 510(k) number K241906. 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® Reinforced Implant?

BioBrace® Reinforced Implant is a medical device that received FDA 510(k) clearance on 2024-07-29. The listed applicant is Conmed Corporation. The 510(k) number is K241906.

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

BioBrace® Reinforced Implant received FDA 510(k) clearance on 2024-07-29, under 510(k) number K241906.

Who is the listed applicant for BioBrace® Reinforced Implant?

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® Reinforced Implant?

The FDA product code for BioBrace® Reinforced Implant is OWW.

Related Clinical Trials

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.

NCT06948591BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction ProceduresRECRUITING

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.

K261363Y-Knotless™ Flex AnchorsK253763Y-Knotless™ Flex AnchorsK252946BioBrace® Extra-Articular Ligament Augmentation KitK251530CONMED Argo Knotless® AnchorK250395BioBrace ® RC Delivery SystemK244025Argo Knotless GENESYS Anchor

View all 48 devices →

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, LLCK242187BioBrace®Conmed 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.

↑