Mg OSTEOREVIVE;Mg OSTEOCRETE
FDA 510(k) K262230 · Bone Solutions, Inc.
510(k) numberK262230
Submission
- Device name
- Mg OSTEOREVIVE;Mg OSTEOCRETE
- Applicant
- Bone Solutions, Inc.
Colleyville, TX, US - Received
- June 30, 2026
- Decision date
- September 11, 2026
- 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 |
|---|---|---|---|
| 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 |
| K251193 | Grafton DBM; Grafton Plus DBM Paste; Magnifuse Bone GraftMQV · Traditional | Medtronic Sofamor Danek, Inc. | 06/12/2025SE |
More from Medtronic Sofamor Danek, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K251522 | Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETEMQV · Traditional | 10/13/2025SE |
| K242372 | Mg OSTEOREVIVE, Mg OSTEOCRETEMQV · Traditional | 10/18/2024SE |
| K234013 | Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETEMQV · Traditional | 02/05/2024SE |
| K221256 | Mg OSTEOINJECTMQV · Traditional | 06/28/2022SE |
| K212991 | OsteoreviveMQV · Traditional | 01/21/2022SE |
| K192674 | Mixing and Delivery SystemFMF · Traditional | 02/18/2020SE |
| K161568 | Bone Solutions Mixing and Delivery SystemFMF · Traditional | 09/16/2016SE |
| K071004 | Osteocrete Bone Void FillerMQV · Traditional | 05/21/2009SE |
Questions and answers
When was Mg OSTEOREVIVE;Mg OSTEOCRETE cleared by the FDA?
Mg OSTEOREVIVE;Mg OSTEOCRETE (K262230) received a 510(k) decision of Substantially Equivalent on September 11, 2026, 73 days after the submission was received.
What is the product code of K262230?
The FDA product code is MQV – Filler, Bone Void, Calcium Compound, a Class II (moderate risk) device regulated under 21 CFR 888.3045.