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FDA 510(k)

NOVABONE-BIOACTIVE SYNTHETIC GRAFT

K-Number: K052494 · 2005-11-03

Decision Date2005-11-03
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NOVABONE-BIOACTIVE SYNTHETIC GRAFT is the device name listed in this FDA 510(k) record. The listed applicant is Novabone Products, LLC. It received FDA 510(k) clearance on 2005-11-03 under 510(k) number K052494. 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 NOVABONE-BIOACTIVE SYNTHETIC GRAFT?

NOVABONE-BIOACTIVE SYNTHETIC GRAFT is a medical device that received FDA 510(k) clearance on 2005-11-03. The listed applicant is Novabone Products, LLC. The 510(k) number is K052494.

When did NOVABONE-BIOACTIVE SYNTHETIC GRAFT receive FDA 510(k) clearance?

NOVABONE-BIOACTIVE SYNTHETIC GRAFT received FDA 510(k) clearance on 2005-11-03, under 510(k) number K052494.

Who is the listed applicant for NOVABONE-BIOACTIVE SYNTHETIC GRAFT?

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

What is the FDA product code for NOVABONE-BIOACTIVE SYNTHETIC GRAFT?

The FDA product code for NOVABONE-BIOACTIVE SYNTHETIC GRAFT 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.

Other records listing Novabone Products, 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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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