The following data is part of a premarket notification filed by Choice Spine with the FDA for Thunderbolt And Lancer Pedicle Screw Systems.
Device ID | K132049 |
510k Number | K132049 |
Device Name: | THUNDERBOLT AND LANCER PEDICLE SCREW SYSTEMS |
Classification | Thoracolumbosacral Pedicle Screw System |
Applicant | CHOICE SPINE 400 ERIN DR. Knoxville, TN 37919 |
Contact | Kim Finch |
Correspondent | Kim Finch CHOICE SPINE 400 ERIN DR. Knoxville, TN 37919 |
Product Code | NKB |
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 | 2013-07-02 |
Decision Date | 2014-08-15 |
Summary: | summary |