LANCER/THUNDERBOLT Pedicle Screw System

GUDID 00840996187411

LANCER,ALIGNING PISTOL REDUCER

Choice Spine, LP

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00840996187411
• NIH Device Record Key: a7578579-13e0-4b98-896a-342559466f95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LANCER/THUNDERBOLT Pedicle Screw System
• Version Model Number: M070-0115A
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840996187411 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132049

FDA Product Code

• LXH: Orthopedic manual surgical instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00840996187411]

Moist Heat or Steam Sterilization

[00840996187411]

Moist Heat or Steam Sterilization

[00840996187411]

Moist Heat or Steam Sterilization

[00840996187411]

Moist Heat or Steam Sterilization

[00840996187411]

Moist Heat or Steam Sterilization

[00840996187411]

Moist Heat or Steam Sterilization

[00840996187411]

Moist Heat or Steam Sterilization

[00840996187411]

Moist Heat or Steam Sterilization

[00840996187411]

Moist Heat or Steam Sterilization

[00840996187411]

Moist Heat or Steam Sterilization

[00840996187411]

Moist Heat or Steam Sterilization

[00840996187411]

Moist Heat or Steam Sterilization

[00840996187411]

Moist Heat or Steam Sterilization

[00840996187411]

Moist Heat or Steam Sterilization

[00840996187411]

Moist Heat or Steam Sterilization

[00840996187411]

Moist Heat or Steam Sterilization

[00840996187411]

Moist Heat or Steam Sterilization

[00840996187411]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-14
• Device Publish Date: 2023-07-06

On-Brand Devices [LANCER/THUNDERBOLT Pedicle Screw System]

• 00840996176118: TBOLT,KWIRE,SS,TROCAR-TROCAR,THRD,24"
• 00840996176101: TBOLT,KWIRE,SS,TROCAR-TROCAR,THRD,22"
• 00840996176095: TBOLT,KWIRE,SS,TROCAR-TROCAR,THRD,20"
• 00840996176088: TBOLT,KWIRE,SS,TROCAR-TROCAR,THRD,18"
• 00840996176071: TBOLT,KWIRE,SS,TROCAR-TROCAR,THRD,12"
• 00840996176064: TBOLT,KWIRE,SS,BLUNT-TROCAR,THRD,24"
• 00840996176057: TBOLT,KWIRE,SS,BLUNT-TROCAR,THRD,22"
• 00840996176040: TBOLT,KWIRE,SS,BLUNT-TROCAR,THRD,20"
• 00840996176033: TBOLT,KWIRE,SS,BLUNT-TROCAR,THRD,18"
• 00840996176026: TBOLT,KWIRE,SS,BLUNT-TROCAR,THRD,12"
• 00840996176019: TBOLT,KWIRE,SS,BLUNT-BLUNT,THRD,24"
• 00840996176002: TBOLT,KWIRE,SS,BLUNT-BLUNT,THRD,22"
• 00840996175999: TBOLT,KWIRE,SS,BLUNT-BLUNT,THRD,20"
• 00840996175982: TBOLT,KWIRE,SS,BLUNT-BLUNT,THRD,18"
• 00840996175975: TBOLT,KWIRE,SS,BLUNT-BLUNT,THRD,12"
• 00840996175968: TBOLT,KWIRE,NIT.,TROCAR-TROCAR,THRD,24"
• 00840996175951: TBOLT,KWIRE,NIT.,TROCAR-TROCAR,THRD,22"
• 00840996175944: TBOLT,KWIRE,NIT.,TROCAR-TROCAR,THRD,20"
• 00840996175937: TBOLT,KWIRE,NIT.,TROCAR-TROCAR,THRD,18"
• 00840996175920: TBOLT,KWIRE,NIT.,TROCAR-TROCAR,THRD,12"
• 00840996175913: TBOLT,KWIRE,NIT.,BLUNT-TROCAR,THRD,24"
• 00840996175906: TBOLT,KWIRE,NIT.,BLUNT-TROCAR,THRD,22"
• 00840996175890: TBOLT,KWIRE,NIT.,BLUNT-TROCAR,THRD,20"
• 00840996175883: TBOLT,KWIRE,NIT.,BLUNT-TROCAR,THRD,18"
• 00840996175876: TBOLT,KWIRE,NIT.,BLUNT-TROCAR,THRD,12"
• 00840996175869: TBOLT,KWIRE,NIT.,BLUNT-BLUNT,THRD,24"
• 00840996175852: TBOLT,KWIRE,NIT.,BLUNT-BLUNT,THRD,22"
• 00840996175845: TBOLT,KWIRE,NIT.,BLUNT-BLUNT,THRD,20"
• 00840996175838: TBOLT,KWIRE,NIT.,BLUNT-BLUNT,THRD,18"
• 00840996175821: TBOLT,KWIRE,NIT.,BLUNT-BLUNT,THRD,12"
• 00840996174039: NAVIGATION,FIELD BLOCK
• 00840996174022: NAVIGATION,FIELD PROBE
• 00840996173902: T'BOLT,KWIRE,SS,TROCAR-TROCAR,LASER,24
• 00840996173896: T'BOLT,KWIRE,SS,TROCAR-TROCAR,LASER,22
• 00840996173889: T'BOLT,KWIRE,SS,TROCAR-TROCAR,LASER,20
• 00840996173872: T'BOLT,KWIRE,SS,TROCAR-TROCAR,LASER,12
• 00840996173865: T'BOLT,KWIRE,SS,BLUNT-TROCAR,LASER,24
• 00840996173858: T'BOLT,KWIRE,SS,BLUNT-TROCAR,LASER,22
• 00840996173841: T'BOLT,KWIRE,SS,BLUNT-TROCAR,LASER,20
• 00840996173834: T'BOLT,KWIRE,SS,BLUNT-TROCAR,LASER,12
• 00840996173827: T'BOLT,KWIRE,SS,BLUNT-BLUNT,LASER,24
• 00840996173810: T'BOLT,KWIRE,SS,BLUNT-BLUNT,LASER,22
• 00840996173803: T'BOLT,KWIRE,SS,BLUNT-BLUNT,LASER,20
• 00840996173797: T'BOLT,KWIRE,SS,BLUNT-BLUNT,LASER,12
• 00840996173780: TBOLT,KWIRE,NITOL,TROCAR-TROCAR,LASER,24
• 00840996173773: TBOLT,KWIRE,NITOL,TROCAR-TROCAR,LASER,22
• 00840996173766: TBOLT,KWIRE,NITOL,TROCAR-TROCAR,LASER,20
• 00840996173759: TBOLT,KWIRE,NITOL,TROCAR-TROCAR,LASER,12
• 00840996173742: T'BOLT,KWIRE,NITOL,BLUNT-TROCAR,LASER,24
• 00840996173735: T'BOLT,KWIRE,NITOL,BLUNT-TROCAR,LASER,22