The following data is part of a premarket notification filed by Biostone Ltd with the FDA for Si-mochi.
| Device ID | K202639 |
| 510k Number | K202639 |
| Device Name: | Si-Mochi |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | Biostone Ltd BioCity, Pennyfoot Street Nottingham, GB Ng1 1gf |
| Contact | Wei-jen Lo |
| Correspondent | Wei-jen Lo Biostone Ltd BioCity, Pennyfoot Street Nottingham, GB Ng1 1gf |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-11 |
| Decision Date | 2021-04-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060548020095 | K202639 | 000 |
| 05060548020125 | K202639 | 000 |
| 05060548020279 | K202639 | 000 |
| 05060548020262 | K202639 | 000 |
| 05060548020255 | K202639 | 000 |
| 05060548020248 | K202639 | 000 |
| 05060548020231 | K202639 | 000 |
| 05060548020224 | K202639 | 000 |
| 05060548020217 | K202639 | 000 |
| 05060548020347 | K202639 | 000 |
| 05060548020330 | K202639 | 000 |
| 05060548020132 | K202639 | 000 |
| 05060548020149 | K202639 | 000 |
| 05060548020101 | K202639 | 000 |
| 05060548020088 | K202639 | 000 |
| 05060548020033 | K202639 | 000 |
| 05060548020026 | K202639 | 000 |
| 05060548020019 | K202639 | 000 |
| 05060548020002 | K202639 | 000 |
| 05060548020200 | K202639 | 000 |
| 05060548020194 | K202639 | 000 |
| 05060548020163 | K202639 | 000 |
| 05060548020156 | K202639 | 000 |
| 05060548020293 | K202639 | 000 |