"Lumbar Spacer System (SABRE, SHARK, HORNET, HARPOON)"

GUDID 00840996188586

PLI,SHAVER,PADDLE,QC,HUDSON,4

Choice Spine, LP

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Primary Device ID	00840996188586
NIH Device Record Key	63e7a196-7699-4fa0-8b14-73000cfff193
Commercial Distribution Status	In Commercial Distribution
Brand Name	"Lumbar Spacer System (SABRE, SHARK, HORNET, HARPOON)"
Version Model Number	P070-2104
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	00840996188586 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K073669

FDA Product Code

LXH	Orthopedic manual surgical instrument