The following data is part of a premarket notification filed by Wiltrom Corporation Limited with the FDA for Bicera (tm) Resorbable Bone Substitute.
| Device ID | K110949 |
| 510k Number | K110949 |
| Device Name: | BICERA (TM) RESORBABLE BONE SUBSTITUTE |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | WILTROM CORPORATION LIMITED NO. 221, SEC 1, CHUNG HSING RD Chutung Township, Hsinchu, TW 31053 |
| Contact | Yung-chih Wu |
| Correspondent | Yung-chih Wu WILTROM CORPORATION LIMITED NO. 221, SEC 1, CHUNG HSING RD Chutung Township, Hsinchu, TW 31053 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-04 |
| Decision Date | 2012-09-18 |
| Summary: | summary |