The following data is part of a premarket notification filed by Curasan Ag with the FDA for Cerasorb Ortho Foam.
| Device ID | K160566 |
| 510k Number | K160566 |
| Device Name: | Cerasorb Ortho Foam |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | CURASAN AG LINDIGSTRASSE 4 Kleinostheim, DE 63801 |
| Contact | Wolf-dietrich Hubner |
| Correspondent | Karin Lubbers YES MEDICAL DEVICE SERVICES GMBH BAHNSTRASSE 42-46 Friedrichsdorf, DE 61381 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-29 |
| Decision Date | 2016-12-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| ECUR449100 | K160566 | 000 |
| ECUR409025 | K160566 | 000 |
| ECUR409050 | K160566 | 000 |
| ECUR409100 | K160566 | 000 |
| ECUR429050 | K160566 | 000 |
| ECUR429100 | K160566 | 000 |
| ECURCOF25100 | K160566 | 000 |
| ECURCOF2550 | K160566 | 000 |
| ECURCOF6565 | K160566 | 000 |
| ECURCOM25100 | K160566 | 000 |
| ECURCOM2512 | K160566 | 000 |
| ECURCOM2525 | K160566 | 000 |
| ECURCOM2550 | K160566 | 000 |
| ECUR449050 | K160566 | 000 |
| ECUR409012 | K160566 | 000 |