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.

Polymeric spinal interbody fusion cage
Primary Device ID00810135960007
NIH Device Record Keyc35a3eb3-bd7f-41f8-9c57-78fbffb7c234
Commercial Distribution StatusIn Commercial Distribution
Brand NameEARP Interbody System
Version Model NumberEARP1425-0008
Company DUNS047486041
Company NameNVISION BIOMEDICAL TECHNOLOGIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone210-598-5641
Emaildiana@nvisionbiomed.com
Phone210-598-5641
Emaildiana@nvisionbiomed.com
Phone210-598-5641
Emaildiana@nvisionbiomed.com
Phone210-598-5641
Emaildiana@nvisionbiomed.com
Phone210-598-5641
Emaildiana@nvisionbiomed.com
Phone210-598-5641
Emaildiana@nvisionbiomed.com
Phone210-598-5641
Emaildiana@nvisionbiomed.com
Phone210-598-5641
Emaildiana@nvisionbiomed.com
Phone210-598-5641
Emaildiana@nvisionbiomed.com
Phone210-598-5641
Emaildiana@nvisionbiomed.com
Phone210-598-5641
Emaildiana@nvisionbiomed.com
Phone210-598-5641
Emaildiana@nvisionbiomed.com
Phone210-598-5641
Emaildiana@nvisionbiomed.com
Phone210-598-5641
Emaildiana@nvisionbiomed.com
Phone210-598-5641
Emaildiana@nvisionbiomed.com
Phone210-598-5641
Emaildiana@nvisionbiomed.com
Phone210-598-5641
Emaildiana@nvisionbiomed.com
Phone210-598-5641
Emaildiana@nvisionbiomed.com
Phone210-598-5641
Emaildiana@nvisionbiomed.com
Phone210-598-5641
Emaildiana@nvisionbiomed.com
Phone210-598-5641
Emaildiana@nvisionbiomed.com
Phone210-598-5641
Emaildiana@nvisionbiomed.com
Phone210-598-5641
Emaildiana@nvisionbiomed.com
Phone210-598-5641
Emaildiana@nvisionbiomed.com
Phone210-598-5641
Emaildiana@nvisionbiomed.com
Phone210-598-5641
Emaildiana@nvisionbiomed.com
Phone210-598-5641
Emaildiana@nvisionbiomed.com
Phone210-598-5641
Emaildiana@nvisionbiomed.com
Phone210-598-5641
Emaildiana@nvisionbiomed.com
Phone210-598-5641
Emaildiana@nvisionbiomed.com
Phone210-598-5641
Emaildiana@nvisionbiomed.com
Phone210-598-5641
Emaildiana@nvisionbiomed.com
Phone210-598-5641
Emaildiana@nvisionbiomed.com
Phone210-598-5641
Emaildiana@nvisionbiomed.com

Device Dimensions

Depth14 Millimeter
Width25 Millimeter
Height8 Millimeter
Depth14 Millimeter
Width25 Millimeter
Height8 Millimeter
Depth14 Millimeter
Width25 Millimeter
Height8 Millimeter
Depth14 Millimeter
Width25 Millimeter
Height8 Millimeter
Depth14 Millimeter
Width25 Millimeter
Height8 Millimeter
Depth14 Millimeter
Width25 Millimeter
Height8 Millimeter
Depth14 Millimeter
Width25 Millimeter
Height8 Millimeter
Depth14 Millimeter
Width25 Millimeter
Height8 Millimeter
Depth14 Millimeter
Width25 Millimeter
Height8 Millimeter
Depth14 Millimeter
Width25 Millimeter
Height8 Millimeter
Depth14 Millimeter
Width25 Millimeter
Height8 Millimeter
Depth14 Millimeter
Width25 Millimeter
Height8 Millimeter
Depth14 Millimeter
Width25 Millimeter
Height8 Millimeter
Depth14 Millimeter
Width25 Millimeter
Height8 Millimeter
Depth14 Millimeter
Width25 Millimeter
Height8 Millimeter
Depth14 Millimeter
Width25 Millimeter
Height8 Millimeter
Depth14 Millimeter
Width25 Millimeter
Height8 Millimeter
Depth14 Millimeter
Width25 Millimeter
Height8 Millimeter
Depth14 Millimeter
Width25 Millimeter
Height8 Millimeter
Depth14 Millimeter
Width25 Millimeter
Height8 Millimeter
Depth14 Millimeter
Width25 Millimeter
Height8 Millimeter
Depth14 Millimeter
Width25 Millimeter
Height8 Millimeter
Depth14 Millimeter
Width25 Millimeter
Height8 Millimeter
Depth14 Millimeter
Width25 Millimeter
Height8 Millimeter
Depth14 Millimeter
Width25 Millimeter
Height8 Millimeter
Depth14 Millimeter
Width25 Millimeter
Height8 Millimeter
Depth14 Millimeter
Width25 Millimeter
Height8 Millimeter
Depth14 Millimeter
Width25 Millimeter
Height8 Millimeter
Depth14 Millimeter
Width25 Millimeter
Height8 Millimeter
Depth14 Millimeter
Width25 Millimeter
Height8 Millimeter
Depth14 Millimeter
Width25 Millimeter
Height8 Millimeter
Depth14 Millimeter
Width25 Millimeter
Height8 Millimeter
Depth14 Millimeter
Width25 Millimeter
Height8 Millimeter
Depth14 Millimeter
Width25 Millimeter
Height8 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100810135960007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-02
Device Publish Date2023-10-25

Devices Manufactured by NVISION BIOMEDICAL TECHNOLOGIES, INC.

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