MQV — Filler, Bone Void, Calcium Compound Class II
FDA product code MQV covers "Filler, Bone Void, Calcium Compound", a Class II medical device regulated under 21 CFR 888.3045. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MQV
- Device Class
- Class II
- Regulation Number
- 888.3045
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260364 | geistlich pharma | Device 300419 Strip | June 2, 2026 |
| K252797 | sdip innovations pty | JAZBI Resorbable Bone Void Filler | May 26, 2026 |
| K261008 | stryker spine | Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioa | April 24, 2026 |
| K253524 | biomendex | Adaptos®Fuse Bone Graft | February 17, 2026 |
| K253147 | prosidyan | FIBERGRAFT BG Putty GPS Bone Graft Substitute FIBERGRAFT BG Putty Bone Graft S | October 22, 2025 |
| K251522 | bone solutions | Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETE | October 13, 2025 |
| K252085 | wright medical technology, inc. (stryker corporation) | Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix | September 30, 2025 |
| K251556 | geistlich pharma | Device 300423 Granules | July 17, 2025 |
| K251720 | surgentec | OsteoFlo HydroFiber | July 2, 2025 |
| K251193 | medtronic sofamor danek | Grafton DBM; Grafton Plus DBM Paste; Magnifuse Bone Graft | June 12, 2025 |
| K243949 | surgentec | OsteoFlo HydroFiber | May 28, 2025 |
| K243474 | kuros biosciences | MagnetOs MIS | May 23, 2025 |
| K250141 | austin medical ventures | Synthecure Synthetic Calcium Sulfate | May 16, 2025 |
| K250521 | biocomposites | NanoBone® SBX Putty ; NanoBone® QD | April 7, 2025 |
| K250556 | ventris medical | Porous Biologic Scaffold | March 21, 2025 |
| K250346 | elute | BonVie+ | February 26, 2025 |
| K241555 | rti surgical | Moldable Bone Void Filler and Moldable Bone Void Filler + CCC | February 21, 2025 |
| K243706 | medtronic sofamor danek | Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft Granul | January 17, 2025 |
| K242782 | noraker | GlassBone Granules | December 23, 2024 |
| K242797 | surgentec | OsteoFlo HydroFiber | December 23, 2024 |