ALIF Anterior Lumbar Interbody Fusion System

GUDID 00814008020003

25x34 10mm 6 Degree

NVISION BIOMEDICAL TECHNOLOGIES, INC.

Polymeric spinal interbody fusion cage
Primary Device ID00814008020003
NIH Device Record Key85136585-faba-490b-8628-251f53eb03fd
Commercial Distribution StatusIn Commercial Distribution
Brand NameALIF Anterior Lumbar Interbody Fusion System
Version Model NumberAL-0610-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

Length25 Millimeter
Length25 Millimeter
Length25 Millimeter
Length25 Millimeter
Length25 Millimeter
Length25 Millimeter
Length25 Millimeter
Length25 Millimeter
Length25 Millimeter
Length25 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100814008020003 [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

[00814008020003]

Moist Heat or Steam Sterilization

[00814008020003]

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

Devices Manufactured by NVISION BIOMEDICAL TECHNOLOGIES, INC.

00810135962155 - Multi-drive Interference Screw2025-05-15 4.0mm Dia X 10mm Long PEEK Interference Screw. The Multi-Drive Interference Screw System is intended for soft tissue reattachm
00810135962162 - Multi-drive Interference Screw2025-05-15 4.0mm Dia X 15mm Long PEEK Interference Screw. The Multi-Drive Interference Screw System is intended for soft tissue reattachm
00810135962179 - Multi-drive Interference Screw2025-05-15 5.0mm Dia X 15mm Long PEEK Interference Screw. The Multi-Drive Interference Screw System is intended for soft tissue reattachm
00810135962186 - Multi-drive Interference Screw2025-05-15 5.0mm Dia X 20mm Long PEEK Interference Screw. The Multi-Drive Interference Screw System is intended for soft tissue reattachm
00810135962193 - Multi-drive Interference Screw2025-05-15 6.0mm Dia X 20mm Long PEEK Interference Screw. The Multi-Drive Interference Screw System is intended for soft tissue reattachm
00810135962209 - Multi-drive Interference Screw2025-05-15 6.0mm Dia X 25mm Long PEEK Interference Screw. The Multi-Drive Interference Screw System is intended for soft tissue reattachm
00810005665179 - Boundary2024-08-16 Buttress Plate Screw 20mm long, 5.5mm circumference, non locking, cancellous. The Boundary Anterior Lumbar Buttress Plate is in
00810005665186 - Boundary2024-08-16 Buttress Plate Screw 25mm long, 5.5mm circumference, non locking, cancellous. The Boundary Anterior Lumbar Buttress Plate is in
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.