ACIF - Anterior Cervical Interbody Fusion System

GUDID 00814008022373

12X14 10mm 6 Degree

NVISION BIOMEDICAL TECHNOLOGIES, INC.

Polymeric spinal interbody fusion cage
Primary Device ID00814008022373
NIH Device Record Key0f0eebc3-a67d-41cd-9e13-f6a2e5222e06
Commercial Distribution StatusIn Commercial Distribution
Brand NameACIF - Anterior Cervical Interbody Fusion System
Version Model NumberAC-610-S
Company DUNS047486041
Company NameNVISION BIOMEDICAL TECHNOLOGIES, INC.
Device Count1
DM Exempttrue
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

Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com

Device Dimensions

Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100814008022373 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODPIntervertebral Fusion Device With Bone Graft, Cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00814008022373]

Moist Heat or Steam Sterilization


[00814008022373]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number7
Public Version Date2020-02-24
Device Publish Date2015-10-19

On-Brand Devices [ACIF - Anterior Cervical Interbody Fusion System]

0081400802255714X16 12mm 6 Degree
0081400802254014X16 11mm 6 Degree
0081400802253314X16 10mm 6 Degree
0081400802252614X16 9mm 6 Degree
0081400802251914X16 8mm 6 Degree
0081400802250214X16 7mm 6 Degree
0081400802249614X16 6mm 6 Degree
0081400802248914X16 5mm 6 Degree
0081400802247214X16 12mm 0 Degree
0081400802246514X16 11mm 0 Degree
0081400802245814X16 10mm 0 Degree
0081400802244114X16 9mm 0 Degree
0081400802243414X16 8mm 0 Degree
0081400802242714X16 7mm 0 Degree
0081400802241014X16 6mm 0 Degree
0081400802240314X16 5mm 0 Degree
0081400802239712X14 12mm 6 Degree
0081400802238012X14 11mm 6 Degree
0081400802237312X14 10mm 6 Degree
0081400802236612X14 9mm 6 Degree
0081400802235912X14 8mm 6 Degree
0081400802234212X14 7mm 6 Degree
0081400802233512X14 6mm 6 Degree
0081400802232812X14 5mm 6 Degree
0081400802231112X14 12mm 0 Degree
0081400802230412X14 11mm 0 Degree
0081400802229812X14 10mm 0 Degree
0081400802228112X14 9mm 0 Degree
0081400802227412X14 8mm 0 Degree
0081400802226712X14 7mm 0 Degree
0081400802225012X14 6mm 0 Degree
0081400802224312X14 5mm 0 Degree

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