Adaptos®Fuse Bone Graft— 510(k) K253524
Substantially EquivalentBiomendex OY
FDA 510(k) clearance K253524 for Adaptos®Fuse Bone Graft, Substantially Equivalent on 2026-02-17. Applicant: Biomendex OY. Device class: 2.
Clearance details
- Applicant
- Biomendex OY
- Product code
- Code MQV
- Device class
- Class 2
- Regulation
- 21 CFR 888.3045
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tampere, FI
Recent devices under product code MQV
view all- K260364 — Device 300419 Strip
- K252797 — JAZBI Resorbable Bone Void Filler
- K261008 — Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip +7 more
- K253147 — FIBERGRAFT BG Putty GPS Bone Graft Substitute FIBERGRAFT BG Putty Bone Graft Substitute FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute FIBERGRAFT BG Matrix Bone Graft Substitute
- K251522 — Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETE
Adverse events under product code MQV
product code MQV- Death
- 6
- Injury
- 435
- Total
- 441
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.