| Primary Device ID | 00840996177214 | 
| NIH Device Record Key | 91ae33de-e079-4f1b-a026-b3c3fc879131 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Thunderbolt Pedicle Screw System | 
| Version Model Number | M070-0132 | 
| Company DUNS | 078293017 | 
| Company Name | Choice Spine, LP | 
| Device Count | 1 | 
| DM Exempt | true | 
| Pre-market Exempt | false | 
| MRI Safety Status | Labeling does not contain MRI Safety Information | 
| Human Cell/Tissue Product | false | 
| Device Kit | false | 
| Device Combination Product | false | 
| Single Use | false | 
| Lot Batch | true | 
| Serial Number | false | 
| Manufacturing Date | false | 
| Expiration Date | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Phone | +1(865)246-3333 | 
| info@choicespine.com | |
| Phone | +1(865)246-3333 | 
| info@choicespine.com | |
| Phone | +1(865)246-3333 | 
| info@choicespine.com | |
| Phone | +1(865)246-3333 | 
| info@choicespine.com | |
| Phone | +1(865)246-3333 | 
| info@choicespine.com | |
| Phone | +1(865)246-3333 | 
| info@choicespine.com | |
| Phone | +1(865)246-3333 | 
| info@choicespine.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00840996177214 [Primary] | 
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[00840996177214]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2019-06-28 | 
| Device Publish Date | 2019-06-20 | 
| 00840996177214 | Thunderbolt Decorticator | 
| 00840996182454 | THUNDERBOLT,NAVIGATION AWL/TAP,4.5MM |