Modification to Cerasorb Ortho
FDA 510(k) K031651 · Curasan AG
510(k) numberK031651
Submission
- Device name
- Modification to Cerasorb Ortho
- Applicant
- Curasan AG
Kleinostheim, DE - Received
- May 28, 2003
- Decision date
- August 13, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K181721 | Ceracell Ortho FoamMQV · Traditional | 09/17/2018SE |
| K160566 | Cerasorb Ortho FoamMQV · Traditional | 12/02/2016SE |
| K111105 | Curasan Osseolive DentalLYC · Abbreviated | 12/20/2012SE |
| K103709 | Ceracell DentalLYC · Abbreviated | 03/10/2011SE |
| K102872 | Osbone DentalLYC · Traditional | 01/12/2011SE |
| K100841 | BoneoptimizerMQV · Special | 08/19/2010SE |
| K063106 | Revois Implant SystemNHA · Abbreviated | 06/11/2007SE |
| K040216 | Cerasorb M OrthoMQV · Special | 03/26/2004SE |
| K014156 | Cerasorb OrthoMQV · Traditional | 03/18/2002SE |
Questions and answers
When was Modification to Cerasorb Ortho cleared by the FDA?
Modification to Cerasorb Ortho (K031651) received a 510(k) decision of Substantially Equivalent on August 13, 2003, 77 days after the submission was received.
What is the product code of K031651?
The FDA product code is MQV – Filler, Bone Void, Calcium Compound, a Class II (moderate risk) device regulated under 21 CFR 888.3045.