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FDA 510(k)

OsteoFlo® HydroPutty™

K-Number: K231716 · 2023-10-02

ApplicantSurGenTec, LLC
Decision Date2023-10-02
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OsteoFlo® HydroPutty™ is the device name listed in this FDA 510(k) record. The listed applicant is SurGenTec, LLC. It received FDA 510(k) clearance on 2023-10-02 under 510(k) number K231716. 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® HydroPutty™?

OsteoFlo® HydroPutty™ is a medical device that received FDA 510(k) clearance on 2023-10-02. The listed applicant is SurGenTec, LLC. The 510(k) number is K231716.

When did OsteoFlo® HydroPutty™ receive FDA 510(k) clearance?

OsteoFlo® HydroPutty™ received FDA 510(k) clearance on 2023-10-02, under 510(k) number K231716.

Who is the listed applicant for OsteoFlo® HydroPutty™?

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® HydroPutty™?

The FDA product code for OsteoFlo® HydroPutty™ is MQV.

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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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