STERISPINE CC

GUDID 03760219913061

SAFE ORTHOPAEDICS

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage

Primary Device ID	03760219913061
NIH Device Record Key	9ff8b757-f3c3-40f6-ae73-2026a7da0446
Commercial Distribution Status	In Commercial Distribution
Brand Name	STERISPINE CC
Version Model Number	KITCCS05S
Company DUNS	261875917
Company Name	SAFE ORTHOPAEDICS
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	false
Expiration Date	true
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	03760219913061 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K162531

FDA Product Code

OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2020-07-06
Device Publish Date	2020-06-26

On-Brand Devices [STERISPINE CC]

03760219913153	KITCCS10L
03760219913146	KITCCS09L
03760219913139	KITCCS08L
03760219913122	KITCCS07L
03760219913115	KITCCS06L
03760219913108	KITCCS05L
03760219913092	KITCCS08S
03760219913085	KITCCS07S
03760219913078	KITCCS06S
03760219913061	KITCCS05S
03760219913054	KITCCANC