The following data is part of a premarket notification filed by Bluestone Synergy with the FDA for Blustone Synergy Lumbar Interbody Fusion System (basalt, Magma, Obsidian), Blustone Synergy Cervical Interbody Fusion System (slate).
| Device ID | K171893 |
| 510k Number | K171893 |
| Device Name: | Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone Synergy Cervical Interbody Fusion System (Slate) |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Bluestone Synergy 5520 Ventana Ct. Pueblo, CO 81005 |
| Contact | Lisa Peterson |
| Correspondent | Lisa Peterson Bluestone Synergy 5520 Ventana Ct. Pueblo, CO 81005 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-26 |
| Decision Date | 2017-09-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810482030019 | K171893 | 000 |
| 00810482030354 | K171893 | 000 |
| 00810482030361 | K171893 | 000 |
| 00810482030378 | K171893 | 000 |
| 00810482030385 | K171893 | 000 |
| 00810482030392 | K171893 | 000 |
| 00810482030408 | K171893 | 000 |
| 00810482030415 | K171893 | 000 |
| 00810482030422 | K171893 | 000 |
| 00810482030347 | K171893 | 000 |
| 00810482030330 | K171893 | 000 |
| 00810482030323 | K171893 | 000 |
| 00810482030026 | K171893 | 000 |
| 00810482030033 | K171893 | 000 |
| 00810482030040 | K171893 | 000 |
| 00810482030057 | K171893 | 000 |
| 00810482030064 | K171893 | 000 |
| 00810482030071 | K171893 | 000 |
| 00810482030309 | K171893 | 000 |
| 00810482030316 | K171893 | 000 |
| 00810482030439 | K171893 | 000 |
| 00810482030446 | K171893 | 000 |
| 00810482030569 | K171893 | 000 |
| 00810482030576 | K171893 | 000 |
| 00810482030583 | K171893 | 000 |
| 00810482030590 | K171893 | 000 |
| 00810482030606 | K171893 | 000 |
| 00810482030613 | K171893 | 000 |
| 00810482030620 | K171893 | 000 |
| 00810482030637 | K171893 | 000 |
| 00810482030552 | K171893 | 000 |
| 00810482030545 | K171893 | 000 |
| 00810482030538 | K171893 | 000 |
| 00810482030453 | K171893 | 000 |
| 00810482030460 | K171893 | 000 |
| 00810482030477 | K171893 | 000 |
| 00810482030484 | K171893 | 000 |
| 00810482030491 | K171893 | 000 |
| 00810482030507 | K171893 | 000 |
| 00810482030514 | K171893 | 000 |
| 00810482030521 | K171893 | 000 |
| 00810482030644 | K171893 | 000 |