LANCER & THUNDERBOLT PEDICLE SCREW SYSTEM

GUDID 00840996192989

THUNDERBOLT,DISTRACTOR

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

Primary Device ID	00840996192989
NIH Device Record Key	0d4feb00-ee04-4bf7-b0c3-930ccadb0cc5
Commercial Distribution Status	In Commercial Distribution
Brand Name	LANCER & THUNDERBOLT PEDICLE SCREW SYSTEM
Version Model Number	M070-0148
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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840996192989 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K132049

FDA Product Code

LXH	Orthopedic manual surgical instrument