The following data is part of a premarket notification filed by Wiltrom Corporation Limited with the FDA for Bicera Resorbable Bone Substitute.
| Device ID | K172237 |
| 510k Number | K172237 |
| Device Name: | Bicera 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 | 2017-07-25 |
| Decision Date | 2018-02-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719873027606 | K172237 | 000 |
| 04719875722028 | K172237 | 000 |
| 04719875722035 | K172237 | 000 |
| 04719875722042 | K172237 | 000 |
| 04719875722059 | K172237 | 000 |
| 04719875722066 | K172237 | 000 |
| 04719875722073 | K172237 | 000 |
| 04719875722080 | K172237 | 000 |
| 04719875722097 | K172237 | 000 |
| 04719875722011 | K172237 | 000 |
| 04719875722004 | K172237 | 000 |
| 04719875721991 | K172237 | 000 |
| 04719875721915 | K172237 | 000 |
| 04719875721922 | K172237 | 000 |
| 04719875721939 | K172237 | 000 |
| 04719875721946 | K172237 | 000 |
| 04719875721953 | K172237 | 000 |
| 04719875721960 | K172237 | 000 |
| 04719875721977 | K172237 | 000 |
| 04719875721984 | K172237 | 000 |
| 04719875722103 | K172237 | 000 |
| 04719875722110 | K172237 | 000 |
| 04719875722233 | K172237 | 000 |
| 04719875722240 | K172237 | 000 |
| 04719875722257 | K172237 | 000 |
| 04719875722264 | K172237 | 000 |
| 04719875722271 | K172237 | 000 |
| 04719875722288 | K172237 | 000 |
| 04719875722295 | K172237 | 000 |
| 04719875722301 | K172237 | 000 |
| 04719875722226 | K172237 | 000 |
| 04719875722219 | K172237 | 000 |
| 04719875722202 | K172237 | 000 |
| 04719875722127 | K172237 | 000 |
| 04719875722134 | K172237 | 000 |
| 04719875722141 | K172237 | 000 |
| 04719875722158 | K172237 | 000 |
| 04719875722165 | K172237 | 000 |
| 04719875722172 | K172237 | 000 |
| 04719875722189 | K172237 | 000 |
| 04719875722196 | K172237 | 000 |
| 04719875722318 | K172237 | 000 |