Thunderbolt™ Minimally Invasive And Lancer™ Open Pedicle Screw Systems
Thoracolumbosacral Pedicle Screw System
CHOICE SPINE LP
The following data is part of a premarket notification filed by Choice Spine Lp with the FDA for Thunderbolt™ Minimally Invasive And Lancer™ Open Pedicle Screw Systems.
Pre-market Notification Details
| Device ID | K160775 |
| 510k Number | K160775 |
| Device Name: | 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 |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-21 |
| Decision Date | 2016-06-03 |
| Summary: | summary |
NIH GUDID Devices
Trademark Results [Thunderbolt]
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