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FDA 510(k)

OsteoFlo HydroFiber

K-Number: K242797 · 2024-12-23

ApplicantSurGenTec, LLC
Decision Date2024-12-23
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OsteoFlo HydroFiber is the device name listed in this FDA 510(k) record. The listed applicant is SurGenTec, LLC. It received FDA 510(k) clearance on 2024-12-23 under 510(k) number K242797. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OsteoFlo HydroFiber?

OsteoFlo HydroFiber is a medical device that received FDA 510(k) clearance on 2024-12-23. The listed applicant is SurGenTec, LLC. The 510(k) number is K242797.

When did OsteoFlo HydroFiber receive FDA 510(k) clearance?

OsteoFlo HydroFiber received FDA 510(k) clearance on 2024-12-23, under 510(k) number K242797.

Who is the listed applicant for OsteoFlo HydroFiber?

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

What is the FDA product code for OsteoFlo HydroFiber?

The FDA product code for OsteoFlo HydroFiber is MQV.

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.

NCT07784673OsteoFlo HydroFiber Ambispective EvaluationENROLLING_BY_INVITATIONNCT06720948The ION Facet Screw System Ambispective EvaluationENROLLING_BY_INVITATION

Other records listing SurGenTec, LLC 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: MQV)

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

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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