OPEL-C

GUDID B16711004220S0

MEDITECH SPINE, LLC

General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit

Primary Device ID	B16711004220S0
NIH Device Record Key	e0ab5daa-ef82-45e7-9807-fb0f98256155
Commercial Distribution Status	In Commercial Distribution
Brand Name	OPEL-C
Version Model Number	1100-422-0S
Company DUNS	182698477
Company Name	MEDITECH SPINE, LLC
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	true
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
HIBCC	B16711004220S0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K160604

FDA Product Code

KWQ	APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY