The following data is part of a premarket notification filed by Choice Spine, Lp with the FDA for The Thunderbolt™ Minimally Invasive And Lancer™ Open Pedicle Screw Systems.
| Device ID | K170942 |
| 510k Number | K170942 |
| Device Name: | The Thunderbolt™ Minimally Invasive And Lancer™ Open Pedicle Screw Systems |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Choice Spine, LP 400 Erin Drive Knoxville, TN 37919 |
| Contact | Kim Finch |
| Correspondent | Kim Finch Choice Spine, LP 400 Erin Drive Knoxville, TN 37919 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-30 |
| Decision Date | 2017-04-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840996164863 | K170942 | 000 |
| 00840996164856 | K170942 | 000 |
| 00840996186209 | K170942 | 000 |