LANCER™/ THUNDERBOLT™ Pedicle Screw System

GUDID 00840996110891

LANCER,THUNDERBOLT,SET SCREW

Choice Spine, LP

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00840996110891
NIH Device Record Key975bbe56-0916-4e23-bdda-3da3ff2b400b
Commercial Distribution StatusIn Commercial Distribution
Brand NameLANCER™/ THUNDERBOLT™ Pedicle Screw System
Version Model NumberMT20-0001
Company DUNS078293017
Company NameChoice Spine, LP
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net

Device Dimensions

Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100840996110891 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBOrthosis, spinal pedicle fixation, for degenerative disc disease

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-24

Devices Manufactured by Choice Spine, LP

00840996182119 - HARRIER-SA Lumbar Interbody System2024-03-05 HARRIER-SA,DRIVER,SPLIT-TIP
00840996150682 - Acapella One2024-03-04 ACAPELLA,TRIAL,LR,NS,12X14X5
00840996150699 - Acapella One2024-03-04 ACAPELLA,TRIAL,LR,NS,12X14X6
00840996150705 - Acapella One2024-03-04 ACAPELLA,TRIAL,LR,NS,12X14X7
00840996150712 - Acapella One2024-03-04 ACAPELLA,TRIAL,LR,NS,12X14X8
00840996150729 - Acapella One2024-03-04 ACAPELLA,TRIAL,LR,NS,12X14X9
00840996150736 - Acapella One2024-03-04 ACAPELLA,TRIAL,LR,NS,12X14X10
00840996150743 - Acapella One2024-03-04 ACAPELLA,TRIAL,LR,NS,12X14X11

Trademark Results [LANCER]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LANCER
LANCER
90256886 not registered Live/Pending
Lancer Corporation
2020-10-15
LANCER
LANCER
88845896 not registered Live/Pending
Albaugh, LLC
2020-03-24
LANCER
LANCER
88822801 not registered Live/Pending
Lancer Skincare LLC
2020-03-05
LANCER
LANCER
88821746 not registered Live/Pending
MITSUBISHI JIDOSHA KOGYO KABUSHIKI KAISHA
2020-03-05
LANCER
LANCER
88083092 5714379 Live/Registered
Lancer Food Service, Inc.
2018-08-17
LANCER
LANCER
87943993 not registered Live/Pending
Lancer Group LLC
2018-05-31
LANCER
LANCER
87943989 not registered Live/Pending
Lancer Group LLC
2018-05-31
LANCER
LANCER
86595418 5207136 Live/Registered
Lancer Systems, LLC
2015-04-13
LANCER
LANCER
85841567 4544495 Live/Registered
LANCER SKINCARE LLC
2013-02-05
LANCER
LANCER
85749776 4508954 Live/Registered
Rocstorage, Inc.
2012-10-09
LANCER
LANCER
85340707 not registered Dead/Abandoned
Cellco Partnership
2011-06-08
LANCER
LANCER
80996743 0996743 Dead/Cancelled
International Buyers Corporation
0000-00-00
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