FDA 510(k)

Mg OSTEOREVIVE™, Mg OSTEOCRETE™

Número K: K242372 · 2024-10-18

Data da decisão2024-10-18

Código do produtoMQV

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Mg OSTEOREVIVE™, Mg OSTEOCRETE™ is the device name listed in this FDA 510(k) record. The listed applicant is Bone Solutions, Inc.. It received FDA 510(k) clearance on 2024-10-18 under 510(k) number K242372. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Mg OSTEOREVIVE™, Mg OSTEOCRETE™?

Mg OSTEOREVIVE™, Mg OSTEOCRETE™ is a medical device that received FDA 510(k) clearance on 2024-10-18. The listed applicant is Bone Solutions, Inc.. The 510(k) number is K242372.

When did Mg OSTEOREVIVE™, Mg OSTEOCRETE™ receive FDA 510(k) clearance?

Mg OSTEOREVIVE™, Mg OSTEOCRETE™ received FDA 510(k) clearance on 2024-10-18, under 510(k) number K242372.

Who is the listed applicant for Mg OSTEOREVIVE™, Mg OSTEOCRETE™?

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

What is the FDA product code for Mg OSTEOREVIVE™, Mg OSTEOCRETE™?

The FDA product code for Mg OSTEOREVIVE™, Mg OSTEOCRETE™ is MQV.

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Outros registros que listam Bone Solutions, Inc. como candidato(a)

K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™K221256Mg OSTEOINJECT K212991Osteorevive K192674Mixing and Delivery System

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Dispositivos Relacionados (Código: MQV)

K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.K260364Device 300419 StripGeistlich Pharma AG K252797JAZBI™ Resorbable Bone Void FillerSdip Innovations Pty, Ltd.K261008Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute; Vitoss BBTrauma® Bioactive Bone Graft Substitute; Vitoss® BA2X Bioactive Bone Graft Substitute; Vitoss® Bioactive Foam Bone Graft Substitute Pack; Vitoss® Bioactive Foam Bone Graft Substitute; Vitoss® Foam Bone Graft Substitute; Vitoss® Bone Graft Substitute Filled Canister; Vitoss® Bone Graft SubstituteStryker Spine K253524Adaptos® Grafto ósseoBiomendex OY K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft Substitute FIBERGRAFT™ AERIDYAN™ Matrix Bone Graft Substitute FIBERGRAFT™ BG Matrix Bone Graft SubstituteProsidyan, Inc.

Fonte oficial

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