LANCER™/ THUNDERBOLT™ Pedicle Screw System
GUDID 00840996110891
LANCER,THUNDERBOLT,SET SCREW
Choice Spine, LP
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 00840996110891 |
| NIH Device Record Key | 975bbe56-0916-4e23-bdda-3da3ff2b400b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LANCER™/ THUNDERBOLT™ Pedicle Screw System |
| Version Model Number | MT20-0001 |
| Company DUNS | 078293017 |
| Company Name | Choice Spine, LP |
| Device Count | 1 |
| DM Exempt | false |
| 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 | true |
| 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 |
Customer Support Contacts
| Phone | +1(865)246-3333 |
| info@choicespine.net | |
| Phone | +1(865)246-3333 |
| info@choicespine.net | |
| Phone | +1(865)246-3333 |
| info@choicespine.net | |
| Phone | +1(865)246-3333 |
| info@choicespine.net | |
| Phone | +1(865)246-3333 |
| info@choicespine.net | |
| Phone | +1(865)246-3333 |
| info@choicespine.net | |
| Phone | +1(865)246-3333 |
| info@choicespine.net | |
| Phone | +1(865)246-3333 |
| info@choicespine.net | |
| Phone | +1(865)246-3333 |
| info@choicespine.net | |
| Phone | +1(865)246-3333 |
| info@choicespine.net | |
| Phone | +1(865)246-3333 |
| info@choicespine.net | |
| Phone | +1(865)246-3333 |
| info@choicespine.net | |
| Phone | +1(865)246-3333 |
| info@choicespine.net | |
| Phone | +1(865)246-3333 |
| info@choicespine.net | |
| Phone | +1(865)246-3333 |
| info@choicespine.net | |
| Phone | +1(865)246-3333 |
| info@choicespine.net | |
| Phone | +1(865)246-3333 |
| info@choicespine.net | |
| Phone | +1(865)246-3333 |
| info@choicespine.net | |
| Phone | +1(865)246-3333 |
| info@choicespine.net | |
| Phone | +1(865)246-3333 |
| info@choicespine.net | |
| Phone | +1(865)246-3333 |
| info@choicespine.net | |
| Phone | +1(865)246-3333 |
| info@choicespine.net | |
| Phone | +1(865)246-3333 |
| info@choicespine.net | |
| Phone | +1(865)246-3333 |
| info@choicespine.net | |
| Phone | +1(865)246-3333 |
| info@choicespine.net | |
| Phone | +1(865)246-3333 |
| info@choicespine.net | |
| Phone | +1(865)246-3333 |
| info@choicespine.net | |
| Phone | +1(865)246-3333 |
| info@choicespine.net | |
| Phone | +1(865)246-3333 |
| info@choicespine.net | |
| Phone | +1(865)246-3333 |
| info@choicespine.net | |
| Phone | +1(865)246-3333 |
| info@choicespine.net | |
| Phone | +1(865)246-3333 |
| info@choicespine.net | |
| Phone | +1(865)246-3333 |
| info@choicespine.net | |
| Phone | +1(865)246-3333 |
| info@choicespine.net |
Device Dimensions
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840996110891 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K132049
FDA Product Code
| NKB | Orthosis, spinal pedicle fixation, for degenerative disc disease |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840996110891]
Moist Heat or Steam Sterilization
[00840996110891]
Moist Heat or Steam Sterilization
[00840996110891]
Moist Heat or Steam Sterilization
[00840996110891]
Moist Heat or Steam Sterilization
[00840996110891]
Moist Heat or Steam Sterilization
[00840996110891]
Moist Heat or Steam Sterilization
[00840996110891]
Moist Heat or Steam Sterilization
[00840996110891]
Moist Heat or Steam Sterilization
[00840996110891]
Moist Heat or Steam Sterilization
[00840996110891]
Moist Heat or Steam Sterilization
[00840996110891]
Moist Heat or Steam Sterilization
[00840996110891]
Moist Heat or Steam Sterilization
[00840996110891]
Moist Heat or Steam Sterilization
[00840996110891]
Moist Heat or Steam Sterilization
[00840996110891]
Moist Heat or Steam Sterilization
[00840996110891]
Moist Heat or Steam Sterilization
[00840996110891]
Moist Heat or Steam Sterilization
[00840996110891]
Moist Heat or Steam Sterilization
[00840996110891]
Moist Heat or Steam Sterilization
[00840996110891]
Moist Heat or Steam Sterilization
[00840996110891]
Moist Heat or Steam Sterilization
[00840996110891]
Moist Heat or Steam Sterilization
[00840996110891]
Moist Heat or Steam Sterilization
[00840996110891]
Moist Heat or Steam Sterilization
[00840996110891]
Moist Heat or Steam Sterilization
[00840996110891]
Moist Heat or Steam Sterilization
[00840996110891]
Moist Heat or Steam Sterilization
[00840996110891]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-10-24 |
Devices Manufactured by Choice Spine, LP
| 00840996182119 - HARRIER-SA Lumbar Interbody System | 2024-03-05 HARRIER-SA,DRIVER,SPLIT-TIP |
| 00840996150682 - Acapella One | 2024-03-04 ACAPELLA,TRIAL,LR,NS,12X14X5 |
| 00840996150699 - Acapella One | 2024-03-04 ACAPELLA,TRIAL,LR,NS,12X14X6 |
| 00840996150705 - Acapella One | 2024-03-04 ACAPELLA,TRIAL,LR,NS,12X14X7 |
| 00840996150712 - Acapella One | 2024-03-04 ACAPELLA,TRIAL,LR,NS,12X14X8 |
| 00840996150729 - Acapella One | 2024-03-04 ACAPELLA,TRIAL,LR,NS,12X14X9 |
| 00840996150736 - Acapella One | 2024-03-04 ACAPELLA,TRIAL,LR,NS,12X14X10 |
| 00840996150743 - Acapella One | 2024-03-04 ACAPELLA,TRIAL,LR,NS,12X14X11 |
Trademark Results [LANCER]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LANCER 90256886 not registered Live/Pending |
Lancer Corporation 2020-10-15 |
 LANCER 88845896 not registered Live/Pending |
Albaugh, LLC 2020-03-24 |
 LANCER 88822801 not registered Live/Pending |
Lancer Skincare LLC 2020-03-05 |
 LANCER 88821746 not registered Live/Pending |
MITSUBISHI JIDOSHA KOGYO KABUSHIKI KAISHA 2020-03-05 |
 LANCER 88083092 5714379 Live/Registered |
Lancer Food Service, Inc. 2018-08-17 |
 LANCER 87943993 not registered Live/Pending |
Lancer Group LLC 2018-05-31 |
 LANCER 87943989 not registered Live/Pending |
Lancer Group LLC 2018-05-31 |
 LANCER 86595418 5207136 Live/Registered |
Lancer Systems, LLC 2015-04-13 |
 LANCER 85841567 4544495 Live/Registered |
LANCER SKINCARE LLC 2013-02-05 |
 LANCER 85749776 4508954 Live/Registered |
Rocstorage, Inc. 2012-10-09 |
 LANCER 85340707 not registered Dead/Abandoned |
Cellco Partnership 2011-06-08 |
 LANCER 80996743 0996743 Dead/Cancelled |
International Buyers Corporation 0000-00-00 |
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