The following data is part of a premarket notification filed by Spinal Analytics & Geometrical Implant Co, Llc with the FDA for Sagico Osi Spinal System By Osimplant.
| Device ID | K180220 |
| 510k Number | K180220 |
| Device Name: | SAGICO OSI Spinal System By Osimplant |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Spinal Analytics & Geometrical Implant Co, LLC 2189 W Busch Blvd Tampa, FL 33612 |
| Contact | James J Gibson Jr. |
| Correspondent | James J Gibson Jr. Spinal Analytics & Geometrical Implant Co, LLC 2189 W Busch Blvd Tampa, FL 33612 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-25 |
| Decision Date | 2018-05-21 |
| Summary: | summary |