MCS Bone Graft
FDA 510(k) K162860 · Bioventus, LLC
510(k) numberK162860
Submission
- Device name
- MCS Bone Graft
- Applicant
- Bioventus, LLC
Durham, NC, US - Received
- October 12, 2016
- Decision date
- February 13, 2017
- 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 |
|---|---|---|
| K253877 | StimTrial Neuromodulation SystemGZF · Special | 08/26/2026SE |
| K243782 | StimTrial Neuromodulation SystemGZF · Traditional | 07/16/2025SE |
| K243678 | TalisMann Neuromodulation SystemGZF · Traditional | 07/03/2025SE |
| K233368 | Allograft Delivery Device (OFAC-C)FMF · Traditional | 06/25/2024SE |
| K233490 | SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyMQV · Traditional | 12/05/2023SE |
| K193513 | SIGNAFUSE Bioactive Bone GraftMQV · Traditional | 06/18/2020SE |
Questions and answers
When was MCS Bone Graft cleared by the FDA?
MCS Bone Graft (K162860) received a 510(k) decision of Substantially Equivalent on February 13, 2017, 124 days after the submission was received.
What is the product code of K162860?
The FDA product code is MQV – Filler, Bone Void, Calcium Compound, a Class II (moderate risk) device regulated under 21 CFR 888.3045.