IDYS-C® ZP 3DTi 44714408

GUDID 03700780636297

WEDGE TRIAL

CLARIANCE

Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial

Primary Device ID	03700780636297
NIH Device Record Key	2e7f02ea-c4d0-45b3-90eb-0be3b51ff845
Commercial Distribution Status	In Commercial Distribution
Brand Name	IDYS-C® ZP 3DTi
Version Model Number	44714408
Catalog Number	44714408
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

Customer Support Contacts

Phone	+1 773 868 7041
Email	s.chambat@clariance-spine.us
Phone	+1 773 868 7041
Email	s.chambat@clariance-spine.us
Phone	+1 773 868 7041
Email	s.chambat@clariance-spine.us
Phone	+1 773 868 7041
Email	s.chambat@clariance-spine.us
Phone	+1 773 868 7041
Email	s.chambat@clariance-spine.us
Phone	+1 773 868 7041
Email	s.chambat@clariance-spine.us
Phone	+1 773 868 7041
Email	s.chambat@clariance-spine.us
Phone	+1 773 868 7041
Email	s.chambat@clariance-spine.us
Phone	+1 773 868 7041
Email	s.chambat@clariance-spine.us
Phone	+1 773 868 7041
Email	s.chambat@clariance-spine.us
Phone	+1 773 868 7041
Email	s.chambat@clariance-spine.us
Phone	+1 773 868 7041
Email	s.chambat@clariance-spine.us
Phone	+1 773 868 7041
Email	s.chambat@clariance-spine.us
Phone	+1 773 868 7041
Email	s.chambat@clariance-spine.us

Device Dimensions

Device Size Text, specify	0
Device Size Text, specify	0
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Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700780636297 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K212562

FDA Product Code

ODP	Intervertebral fusion device with bone graft, cervical