The following data is part of a premarket notification filed by Dimensional Bioceramics, Llc with the FDA for Db-orthopedics.
| Device ID | K200752 |
| 510k Number | K200752 |
| Device Name: | DB-Orthopedics |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | Dimensional Bioceramics, LLC 2161 Delaware Ave., Suite A Santa Cruz, CA 95060 |
| Contact | Duran N. Yetkinler |
| Correspondent | Patsy J. Trisler Trisler Consulting 7949 Beaumont Green East Dr Indianapolis, IN 46250 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-23 |
| Decision Date | 2020-04-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850018568074 | K200752 | 000 |
| 00850018568067 | K200752 | 000 |
| 00850018568050 | K200752 | 000 |
| 00850018568043 | K200752 | 000 |
| 00850018568036 | K200752 | 000 |
| 00850018568029 | K200752 | 000 |
| 00850018568012 | K200752 | 000 |
| 00850018568005 | K200752 | 000 |