EARP INSTRUMENTS

GUDID 00810135960779

EARP, TRIAL 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.

General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit
Primary Device ID00810135960779
NIH Device Record Key77950fe2-73e9-4343-ba12-b9981c643c12
Commercial Distribution StatusIn Commercial Distribution
Brand NameEARP INSTRUMENTS
Version Model NumberEARP-T-1425-0008
Company DUNS047486041
Company NameNVISION BIOMEDICAL TECHNOLOGIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
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

Device Dimensions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100810135960779 [Primary]

FDA Product Code

MDMInstrument, Manual, Surgical, General Use

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810135960779]

Moist Heat or Steam Sterilization

[00810135960779]

Moist Heat or Steam Sterilization

[00810135960779]

Moist Heat or Steam Sterilization

[00810135960779]

Moist Heat or Steam Sterilization

[00810135960779]

Moist Heat or Steam Sterilization

[00810135960779]

Moist Heat or Steam Sterilization

[00810135960779]

Moist Heat or Steam Sterilization

[00810135960779]

Moist Heat or Steam Sterilization

[00810135960779]

Moist Heat or Steam Sterilization

[00810135960779]

Moist Heat or Steam Sterilization

[00810135960779]

Moist Heat or Steam Sterilization

[00810135960779]

Moist Heat or Steam Sterilization

[00810135960779]

Moist Heat or Steam Sterilization

[00810135960779]

Moist Heat or Steam Sterilization

[00810135960779]

Moist Heat or Steam Sterilization

[00810135960779]

Moist Heat or Steam Sterilization

[00810135960779]

Moist Heat or Steam Sterilization

[00810135960779]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-26
Device Publish Date2023-10-18

On-Brand Devices [EARP INSTRUMENTS]

00810135961103EARP RETRACTOR TRAY. The EARP Interbody System is intended for intervertebral body fusion in t
00810135961097EARP INSTRUMENT AND IMPLANT TRAY. The EARP Interbody System is intended for intervertebral bod
00810135961059EARP DISC RAKE ANGLED. The EARP Interbody System is intended for intervertebral body fusion i
00810135961042EARP DISC RAKE The EARP Interbody System is intended for intervertebral body fusion in the lumb
00810135961035EARP, IMPLANT CADDIE 22X45. The EARP Interbody System is intended for intervertebral body fus
00810135961028EARP, IMPLANT CADDIE 22X40. The EARP Interbody System is intended for intervertebral body fus
00810135961011EARP, IMPLANT CADDIE 22X35. The EARP Interbody System is intended for intervertebral body fus
00810135961004EARP, IMPLANT CADDIE 18X45. The EARP Interbody System is intended for intervertebral body fus
00810135960991EARP, IMPLANT CADDIE 18X40. The EARP Interbody System is intended for intervertebral body fus
00810135960984EARP, IMPLANT CADDIE 18X35. The EARP Interbody System is intended for intervertebral body fus
00810135960977EARP, IMPLANT CADDIE 18X30. The EARP Interbody System is intended for intervertebral body fus
00810135960960EARP, IMPLANT CADDIE 14X40. The EARP Interbody System is intended for intervertebral body fus
00810135960953EARP, IMPLANT CADDIE 14X35. The EARP Interbody System is intended for intervertebral body fus
00810135960946EARP, IMPLANT CADDIE 14X30. The EARP Interbody System is intended for intervertebral body fus
00810135960939EARP, IMPLANT CADDIE 14X25. The EARP Interbody System is intended for intervertebral body fus
00810135960922EARP, DISC SPACER CADDIE. The EARP Interbody System is intended for intervertebral body fusio
00810135960915EARP, TRIAL CADDIE The EARP Interbody System is intended for intervertebral body fusion in th
00810135960908EARP, TRIAL 22X35X14 12° The EARP Interbody System is intended for intervertebral body fusio
00810135960892EARP, TRIAL 22X35X12 12° The EARP Interbody System is intended for intervertebral body fusio
00810135960885EARP, TRIAL 22X35X14 6° The EARP Interbody System is intended for intervertebral body fusion
00810135960878EARP, TRIAL 22X35X12 6° The EARP Interbody System is intended for intervertebral body fusion
00810135960861EARP, TRIAL 22X35X10 6° The EARP Interbody System is intended for intervertebral body fusion
00810135960854EARP, TRIAL 18X35X14 12° The EARP Interbody System is intended for intervertebral body fusio
00810135960847EARP, TRIAL 18X35X12 12° The EARP Interbody System is intended for intervertebral body fusio
00810135960830EARP, TRIAL 18X35X14 6° The EARP Interbody System is intended for intervertebral body fusion
00810135960823EARP, TRIAL 18X35X12 6° The EARP Interbody System is intended for intervertebral body fusion
00810135960816EARP, TRIAL 18X35X10 6° The EARP Interbody System is intended for intervertebral body fusion
00810135960809EARP, TRIAL 18X35X08 0° The EARP Interbody System is intended for intervertebral body fusion
00810135960793EARP, TRIAL 14X35X10 0° The EARP Interbody System is intended for intervertebral body fusion
00810135960786EARP, TRIAL 14X35X08 0° The EARP Interbody System is intended for intervertebral body fusion
00810135960779EARP, TRIAL 14X25X08 0° The EARP Interbody System is intended for intervertebral body fusion
00810135960649RETRACTABLE OSTEOTOME. The EARP Interbody System is intended for intervertebral body fusion
00810135960632EARP FINAL INSERTER. The EARP Interbody System is intended for intervertebral body fusion in
00810135960625EARP INITIAL INSERTER. The EARP Interbody System is intended for intervertebral body fusion
00810135960618EARP DISC SPACER INSERTER. The EARP Interbody System is intended for intervertebral body fus
00810135960601EARP DISC SPACER 14MM The EARP Interbody System is intended for intervertebral body fusion i
00810135960595EARP DISC SPACER 12MM The EARP Interbody System is intended for intervertebral body fusion i
00810135960588EARP DISC SPACER 10MM The EARP Interbody System is intended for intervertebral body fusion i
00810135960571EARP DISC SPACER 8MM The EARP Interbody System is intended for intervertebral body fusion in
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