OIC Pedicle Screw System

GUDID M696SP200140

5.5MM BONE TAP

ORTHOPAEDIC IMPLANT COMPANY, THE

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Primary Device ID	M696SP200140
NIH Device Record Key	961484cf-77f3-4b53-a841-6498500ed4eb
Commercial Distribution Status	In Commercial Distribution
Brand Name	OIC Pedicle Screw System
Version Model Number	SP20014
Company DUNS	070061160
Company Name	ORTHOPAEDIC IMPLANT COMPANY, THE
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	true
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	775 636 8281
Email	Info@OrthoImplantCompany.com
Phone	775 636 8281
Email	Info@OrthoImplantCompany.com
Phone	775 636 8281
Email	Info@OrthoImplantCompany.com
Phone	775 636 8281
Email	Info@OrthoImplantCompany.com
Phone	775 636 8281
Email	Info@OrthoImplantCompany.com
Phone	775 636 8281
Email	Info@OrthoImplantCompany.com
Phone	775 636 8281
Email	Info@OrthoImplantCompany.com
Phone	775 636 8281
Email	Info@OrthoImplantCompany.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M696SP200140 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K110046

FDA Product Code

MNI	Orthosis, Spinal Pedicle Fixation