EARP Interbody System

GUDID 00810135960007

EARP, 14X25X08 0° The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

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Primary Device ID	00810135960007
NIH Device Record Key	c35a3eb3-bd7f-41f8-9c57-78fbffb7c234
Commercial Distribution Status	In Commercial Distribution
Brand Name	EARP Interbody System
Version Model Number	EARP1425-0008
Company DUNS	047486041
Company Name	NVISION BIOMEDICAL TECHNOLOGIES, INC.
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	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	210-598-5641
Email	diana@nvisionbiomed.com
Phone	210-598-5641
Email	diana@nvisionbiomed.com
Phone	210-598-5641
Email	diana@nvisionbiomed.com
Phone	210-598-5641
Email	diana@nvisionbiomed.com
Phone	210-598-5641
Email	diana@nvisionbiomed.com
Phone	210-598-5641
Email	diana@nvisionbiomed.com
Phone	210-598-5641
Email	diana@nvisionbiomed.com
Phone	210-598-5641
Email	diana@nvisionbiomed.com
Phone	210-598-5641
Email	diana@nvisionbiomed.com
Phone	210-598-5641
Email	diana@nvisionbiomed.com
Phone	210-598-5641
Email	diana@nvisionbiomed.com
Phone	210-598-5641
Email	diana@nvisionbiomed.com
Phone	210-598-5641
Email	diana@nvisionbiomed.com
Phone	210-598-5641
Email	diana@nvisionbiomed.com
Phone	210-598-5641
Email	diana@nvisionbiomed.com
Phone	210-598-5641
Email	diana@nvisionbiomed.com
Phone	210-598-5641
Email	diana@nvisionbiomed.com

Device Dimensions

Depth	14 Millimeter
Width	25 Millimeter
Height	8 Millimeter
Depth	14 Millimeter
Width	25 Millimeter
Height	8 Millimeter
Depth	14 Millimeter
Width	25 Millimeter
Height	8 Millimeter
Depth	14 Millimeter
Width	25 Millimeter
Height	8 Millimeter
Depth	14 Millimeter
Width	25 Millimeter
Height	8 Millimeter
Depth	14 Millimeter
Width	25 Millimeter
Height	8 Millimeter
Depth	14 Millimeter
Width	25 Millimeter
Height	8 Millimeter
Depth	14 Millimeter
Width	25 Millimeter
Height	8 Millimeter
Depth	14 Millimeter
Width	25 Millimeter
Height	8 Millimeter
Depth	14 Millimeter
Width	25 Millimeter
Height	8 Millimeter
Depth	14 Millimeter
Width	25 Millimeter
Height	8 Millimeter
Depth	14 Millimeter
Width	25 Millimeter
Height	8 Millimeter
Depth	14 Millimeter
Width	25 Millimeter
Height	8 Millimeter
Depth	14 Millimeter
Width	25 Millimeter
Height	8 Millimeter
Depth	14 Millimeter
Width	25 Millimeter
Height	8 Millimeter
Depth	14 Millimeter
Width	25 Millimeter
Height	8 Millimeter
Depth	14 Millimeter
Width	25 Millimeter
Height	8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810135960007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K212477

FDA Product Code

MAX	Intervertebral Fusion Device With Bone Graft, Lumbar