FDA 510(k)

FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute

Número K: K182670 · 2018-12-20

Data da decisão2018-12-20

Código do produtoMQV

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute is the device name listed in this FDA 510(k) record. The listed applicant is Prosidyan, Inc.. It received FDA 510(k) clearance on 2018-12-20 under 510(k) number K182670. 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 FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute?

FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute is a medical device that received FDA 510(k) clearance on 2018-12-20. The listed applicant is Prosidyan, Inc.. The 510(k) number is K182670.

When did FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute receive FDA 510(k) clearance?

FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute received FDA 510(k) clearance on 2018-12-20, under 510(k) number K182670.

Who is the listed applicant for FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute?

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

What is the FDA product code for FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute?

The FDA product code for FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute is MQV.

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

K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft Substitute FIBERGRAFT™ AERIDYAN™ Matrix Bone Graft Substitute FIBERGRAFT™ BG Matrix Bone Graft Substitute K251648GPS Advanced; GPS Advanced Cannula K241426GPS Advanced; 5 cc GPS Advanced Cannula K213803FIBERGRAFT Aeridyan Matrix Bone Graft Substitute K180080FIBERGRAFT BG Matrix Bone Graft Substitute K171284FIBERGRAFT BG Matrix Bone Graft Substitute

Ver todos os 8 dispositivos →

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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