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FDA 510(k)

EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )

K-Number: K243609 · 2024-12-18

ApplicantEtex Corporation
Decision Date2024-12-18
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone ) is a medical device manufactured by Etex Corporation. It received FDA 510(k) clearance on 2024-12-18 under approval number K243609. 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 EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )?

EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone ) is a medical device that received FDA 510(k) clearance on 2024-12-18. It is manufactured by Etex Corporation. The 510(k) number is K243609.

When was EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone ) approved by the FDA?

EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone ) received FDA 510(k) clearance on 2024-12-18, under approval number K243609.

What company makes EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )?

EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone ) is manufactured by Etex Corporation.

What is the FDA product code for EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )?

The FDA product code for EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone ) is MQV.

Related Clinical Trials

NCT01234415 Bone Substitute in the Multi Traumatized Nasal Septum Reconstruction COMPLETED NCT07059065 FIBERGRAFT Aeridyan Posterolateral Fusion Study RECRUITING NCT07569146 Assessment of Deproteinized Bovine Bone for Immediate Implants Placement in Maxillary Esthetic Zone. COMPLETED NCT05706909 The Use of Genex in the Management of Early-Stage Osteonecrosis of the Femoral Head ACTIVE_NOT_RECRUITING NCT07500961 Novel Bone Substitute (ALBO-OS) in Patients With Periodontal Disease or Who Need Alveolar Preservation COMPLETED

Other Devices by Etex Corporation

K182107CarriGen PF

Related Devices (Code: MQV)

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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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