DSM Biomedical Calcium Phosphate Cement
FDA 510(k) K173362 · Kensey Nash Corporation Dba Dsm Biomedical
510(k) numberK173362
Submission
- Device name
- DSM Biomedical Calcium Phosphate Cement
- Applicant
- Kensey Nash Corporation Dba Dsm Biomedical
Exton, PA, US - Received
- October 26, 2017
- Decision date
- April 3, 2018
- 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 |
|---|---|---|
| K173572 | DSM Biomedical Calcium Phosphate Cement with MicrospheresMQV · Traditional | 05/09/2018SE |
| K170245 | DSM Biomedical Dental Bone GraftNPM · Traditional | 05/16/2017SE |
| K160474 | DSM Biomedical Porcine Pericardium Dental MembraneNPL · Traditional | 06/07/2016SE |
| K141738 | Medeor Matrix Wound DressingKGN · Traditional | 02/17/2015SE |
| K133169 | Meso Tendon MatrixOWY · Traditional | 12/20/2013SE |
| K132025 | Meso Bilayer Surgical MeshFTM · Traditional | 10/30/2013SE |
Questions and answers
When was DSM Biomedical Calcium Phosphate Cement cleared by the FDA?
DSM Biomedical Calcium Phosphate Cement (K173362) received a 510(k) decision of Substantially Equivalent on April 3, 2018, 159 days after the submission was received.
What is the product code of K173362?
The FDA product code is MQV – Filler, Bone Void, Calcium Compound, a Class II (moderate risk) device regulated under 21 CFR 888.3045.