The following data is part of a premarket notification filed by Wiltrom Corporation Limited with the FDA for Osteocera Resorbable Bone Substitute.
| Device ID | K180758 |
| 510k Number | K180758 |
| Device Name: | Osteocera Resorbable Bone Substitute |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | Wiltrom Corporation Limited 1F., No. 26, Sec. 2, Shengyi Rd. Zhubei City, TW 30261 |
| Contact | Yi-chun Su |
| Correspondent | Yi-chun Su Wiltrom Corporation Limited 1F., No. 26, Sec. 2, Shengyi Rd. Zhubei City, TW 30261 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-22 |
| Decision Date | 2018-10-24 |
| Summary: | summary |