Grafton DBM; Grafton Plus DBM Paste; Magnifuse Bone Graft
FDA 510(k) K251193 · Medtronic Sofamor Danek, Inc.
510(k) numberK251193
Submission
- Device name
- Grafton DBM; Grafton Plus DBM Paste; Magnifuse Bone Graft
- Applicant
- Medtronic Sofamor Danek, Inc.
Memphis, TN, US - Received
- April 17, 2025
- Decision date
- June 12, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQV – Filler, Bone Void, Calcium Compound
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3045
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MQV
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262230 | Mg OSTEOREVIVE;Mg OSTEOCRETEMQV · Traditional | Bone Solutions, Inc. | 09/11/2026SE |
| K260364 | Device 300419 StripMQV · Traditional | Geistlich Pharma AG | 06/02/2026SE |
| K252797 | JAZBI Resorbable Bone Void FillerMQV · Traditional | Sdip Innovations Pty, Ltd. | 05/26/2026SE |
| K261008 | Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive…MQV · Special | Stryker Spine | 04/24/2026SE |
| K253524 | Adaptos®Fuse Bone GraftMQV · Traditional | Biomendex OY | 02/17/2026SE |
| K253147 | FIBERGRAFT BG Putty GPS Bone Graft Substitute FIBERGRAFT BG Putty Bone Graft…MQV · Special | Prosidyan, Inc. | 10/22/2025SE |
| K251522 | Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETEMQV · Traditional | Bone Solutions, Inc. | 10/13/2025SE |
| K252085 | Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)MQV · Traditional | Wright Medical Technology, Inc. (Stryker… | 09/30/2025SE |
| K251556 | Device 300423 GranulesMQV · Traditional | Geistlich Pharma AG | 07/17/2025SE |
| K251720 | OsteoFlo HydroFiberMQV · Special | SurGenTec, LLC | 07/02/2025SE |
More from SurGenTec, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K243706 | Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMQV · Traditional | 01/17/2025SE |
| K230716 | Robotic Graft Delivery InstrumentsOLO · Traditional | 07/18/2023SE |
| K212428 | Centerpiece Plate Fixation SystemNQW · Traditional | 12/13/2021SE |
| K201267 | Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMAX · Traditional | 08/26/2020SE |
| K173125 | T2 STRATOSPHERE Expandable Corpectomy SystemMQP · Traditional | 12/20/2017SE |
| K172199 | ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…MAX · Traditional | 09/19/2017SE |
| K171031 | CRESCENT Spinal SystemMAX · Special | 07/06/2017SE |
| K171468 | FUSE Spinal SystemMAX · Special | 06/13/2017SE |
| K170679 | CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…NKB · Traditional | 05/11/2017SE |
| K161210 | RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM)…OUR · Traditional | 08/12/2016SE |
Questions and answers
When was Grafton DBM; Grafton Plus DBM Paste; Magnifuse Bone Graft cleared by the FDA?
Grafton DBM; Grafton Plus DBM Paste; Magnifuse Bone Graft (K251193) received a 510(k) decision of Substantially Equivalent on June 12, 2025, 56 days after the submission was received.
What is the product code of K251193?
The FDA product code is MQV – Filler, Bone Void, Calcium Compound, a Class II (moderate risk) device regulated under 21 CFR 888.3045.