Medyssey Spinal System - Rod

GUDID 08800042402846

Z-Shaped Pre-bending Rod, Ø6.0mm, 80mm Length

Medyssey Co., Ltd.

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	08800042402846
NIH Device Record Key	745fb44e-8536-4b23-bff1-6441f4051ba0
Commercial Distribution Discontinuation	2023-11-21
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	Medyssey Spinal System - Rod
Version Model Number	ZR60080
Company DUNS	688211503
Company Name	Medyssey Co., Ltd.
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	false
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	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800042402846 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K181978

FDA Product Code

NKB	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease