The following data is part of a premarket notification filed by Spinal Analytics & Geometrical Impant Co, Llc with the FDA for Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion Cervical.
| Device ID | K161710 |
| 510k Number | K161710 |
| Device Name: | SAGICO IBF SYSTEM – ARIA LUMBAR, SAGICO IBF SYSTEM – ARION CERVICAL |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | SPINAL ANALYTICS & GEOMETRICAL IMPANT CO, LLC 2189 W BUSCH BLVD Tampa, FL 33612 |
| Contact | James J Gibson |
| Correspondent | James J Gibson SPINAL ANALYTICS & GEOMETRICAL IMPANT CO, LLC 2189 WEST BUSCH BOULEVARD Tampa, FL 33612 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-21 |
| Decision Date | 2017-06-29 |
| Summary: | summary |