Quantum Spinal Fixation System 10-PJC5001070-R

GUDID 00846468090500

PRE CONTOURED, J-ROD, RIGHT

Pioneer Surgical Technology, Inc.

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	00846468090500
NIH Device Record Key	9470cae0-877f-460d-bca3-db590817ac71
Commercial Distribution Status	In Commercial Distribution
Brand Name	Quantum Spinal Fixation System
Version Model Number	10-PJC5001070-R
Catalog Number	10-PJC5001070-R
Company DUNS	793384496
Company Name	Pioneer Surgical Technology, Inc.
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(386)418-8888
Email	labeling@rtix.com
Phone	+1(386)418-8888
Email	labeling@rtix.com
Phone	+1(386)418-8888
Email	labeling@rtix.com
Phone	+1(386)418-8888
Email	labeling@rtix.com
Phone	+1(386)418-8888
Email	labeling@rtix.com
Phone	+1(386)418-8888
Email	labeling@rtix.com
Phone	+1(386)418-8888
Email	labeling@rtix.com
Phone	+1(386)418-8888
Email	labeling@rtix.com
Phone	+1(386)418-8888
Email	labeling@rtix.com
Phone	+1(386)418-8888
Email	labeling@rtix.com
Phone	+1(386)418-8888
Email	labeling@rtix.com
Phone	+1(386)418-8888
Email	labeling@rtix.com
Phone	+1(386)418-8888
Email	labeling@rtix.com
Phone	+1(386)418-8888
Email	labeling@rtix.com
Phone	+1(386)418-8888
Email	labeling@rtix.com
Phone	+1(386)418-8888
Email	labeling@rtix.com
Phone	+1(386)418-8888
Email	labeling@rtix.com

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00846468090500 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K101790

FDA Product Code

NKB	Thoracolumbosacral pedicle screw system