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FDA 510(k)

Adaptos®Fuse Bone Graft

K-Number: K253524 · 2026-02-17

ApplicantBiomendex OY
Decision Date2026-02-17
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Adaptos®Fuse Bone Graft is the device name listed in this FDA 510(k) record. The listed applicant is Biomendex OY. It received FDA 510(k) clearance on 2026-02-17 under 510(k) number K253524. 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 Adaptos®Fuse Bone Graft?

Adaptos®Fuse Bone Graft is a medical device that received FDA 510(k) clearance on 2026-02-17. The listed applicant is Biomendex OY. The 510(k) number is K253524.

When did Adaptos®Fuse Bone Graft receive FDA 510(k) clearance?

Adaptos®Fuse Bone Graft received FDA 510(k) clearance on 2026-02-17, under 510(k) number K253524.

Who is the listed applicant for Adaptos®Fuse Bone Graft?

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

What is the FDA product code for Adaptos®Fuse Bone Graft?

The FDA product code for Adaptos®Fuse Bone Graft is MQV.

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.

K260364Device 300419 StripGeistlich Pharma AGK252797JAZBI™ 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 SpineK253147FIBERGRAFT™ 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.K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.K252085Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)Wright Medical Technology, Inc. (Stryker Corporation)

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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