The following data is part of a premarket notification filed by Blustone Synergy with the FDA for Blustone Synergy Silica System.
| Device ID | K172330 |
| 510k Number | K172330 |
| Device Name: | Blustone Synergy Silica System |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | Blustone Synergy 5520 Ventana Ct. Pueblo, CO 81005 |
| Contact | Lisa Peterson |
| Correspondent | Lisa Peterson Kaedon Consulting LLC 14001 Hunters Pass Austin, TX 78734 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-02 |
| Decision Date | 2017-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810482030293 | K172330 | 000 |
| 00810482030170 | K172330 | 000 |
| 00810482030163 | K172330 | 000 |
| 00810482030156 | K172330 | 000 |
| 00810482030149 | K172330 | 000 |
| 00810482030132 | K172330 | 000 |
| 00810482030125 | K172330 | 000 |
| 00810482030118 | K172330 | 000 |
| 00810482030101 | K172330 | 000 |
| 00810482030095 | K172330 | 000 |
| 00810482030187 | K172330 | 000 |
| 00810482030194 | K172330 | 000 |
| 00810482030286 | K172330 | 000 |
| 00810482030279 | K172330 | 000 |
| 00810482030262 | K172330 | 000 |
| 00810482030255 | K172330 | 000 |
| 00810482030248 | K172330 | 000 |
| 00810482030231 | K172330 | 000 |
| 00810482030224 | K172330 | 000 |
| 00810482030217 | K172330 | 000 |
| 00810482030200 | K172330 | 000 |
| 00810482030088 | K172330 | 000 |