Erisma®-MIS 13435065

GUDID 03700780644094

MIS PRE-LORDOSED ROD

CLARIANCE

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 Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

Primary Device ID	03700780644094
NIH Device Record Key	b12abf5d-e6d8-4cbe-b5cd-0a0f072d8299
Commercial Distribution Status	In Commercial Distribution
Brand Name	Erisma®-MIS
Version Model Number	13435065
Catalog Number	13435065
Company DUNS	296568400
Company Name	CLARIANCE
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	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

Device Dimensions

Outer Diameter	5.5 Millimeter
Length	80 Millimeter
Outer Diameter	5.5 Millimeter
Length	80 Millimeter
Outer Diameter	5.5 Millimeter
Length	80 Millimeter
Outer Diameter	5.5 Millimeter
Length	80 Millimeter
Outer Diameter	5.5 Millimeter
Length	80 Millimeter
Outer Diameter	5.5 Millimeter
Length	80 Millimeter
Outer Diameter	5.5 Millimeter
Length	80 Millimeter
Outer Diameter	5.5 Millimeter
Length	80 Millimeter
Outer Diameter	5.5 Millimeter
Length	80 Millimeter
Outer Diameter	5.5 Millimeter
Length	80 Millimeter
Outer Diameter	5.5 Millimeter
Length	80 Millimeter
Outer Diameter	5.5 Millimeter
Length	80 Millimeter
Outer Diameter	5.5 Millimeter
Length	80 Millimeter
Outer Diameter	5.5 Millimeter
Length	80 Millimeter
Outer Diameter	5.5 Millimeter
Length	80 Millimeter
Outer Diameter	5.5 Millimeter
Length	80 Millimeter
Outer Diameter	5.5 Millimeter
Length	80 Millimeter
Outer Diameter	5.5 Millimeter
Length	80 Millimeter
Outer Diameter	5.5 Millimeter
Length	80 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700780644094 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K162367

FDA Product Code

MNH	Orthosis, Spondylolisthesis Spinal Fixation