nva

GUDID 90814008024417

ALIF Encoded 25x34 10mm 6 Degree

NVISION BIOMEDICAL TECHNOLOGIES, INC.

Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage
Primary Device ID90814008024417
NIH Device Record Keyd6200a2f-4616-4c34-91c4-a22f00db5a60
Commercial Distribution StatusIn Commercial Distribution
Brand Namenva
Version Model NumberALE-0610-S
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

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

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
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Device Identifiers

Device Issuing AgencyDevice ID
GS190814008024417 [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

[90814008024417]

Moist Heat or Steam Sterilization


[90814008024417]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2020-02-24
Device Publish Date2017-05-15

On-Brand Devices [nva]

00814008020621Caddy Lid, Anterior Lumbar Interbody Fusion System (ALIF)
00814008020591Caddy Base for 29 X 39 implants, Anterior Lumbar Interbody Fusion System (ALIF)
00814008020584Caddy Base for 25 X 34 implants, Anterior Lumbar Interbody Fusion System (ALIF)
00814008020560ALIF Tray 1, Anterior Lumbar Interbody Fusion System (ALIF)
00814008020557ALIF Tray 2, Anterior Lumbar Interbody Fusion System (ALIF)
00814008020553Case Lid, Anterior Lumbar Interbody Fusion System (ALIF)
00814008020546Case Base, Anterior Lumbar Interbody Fusion System (ALIF)
00814008020539Instrument, Trial Large, Anterior Lumbar Interbody Fusion System (ALIF)
00814008020522Instrument, Trial Large, Anterior Lumbar Interbody Fusion System (ALIF)
00814008020515Instrument, Trial Large, Anterior Lumbar Interbody Fusion System (ALIF)
00814008020508Instrument, Trial Large, Anterior Lumbar Interbody Fusion System (ALIF)
00814008020492Instrument, Trial Large, Anterior Lumbar Interbody Fusion System (ALIF)
00814008020485Instrument, Trial Large, Anterior Lumbar Interbody Fusion System (ALIF)
00814008020478Instrument, Trial Large, Anterior Lumbar Interbody Fusion System (ALIF)
00814008020461Instrument, Trial Large, Anterior Lumbar Interbody Fusion System (ALIF)
00814008020454Instrument, Trial Large, Anterior Lumbar Interbody Fusion System (ALIF)
00814008020447Instrument, Trial Large, Anterior Lumbar Interbody Fusion System (ALIF)
00814008020430Instrument, Trial Large, Anterior Lumbar Interbody Fusion System (ALIF)
00814008020423Instrument, Trial Large, Anterior Lumbar Interbody Fusion System (ALIF)
00814008020416Instrument, Trial Small, Anterior Lumbar Interbody Fusion System (ALIF)
00814008020409Instrument, Trial Small, Anterior Lumbar Interbody Fusion System (ALIF)
00814008020393Instrument, Trial Small, Anterior Lumbar Interbody Fusion System (ALIF)
00814008020386Instrument, Trial Small, Anterior Lumbar Interbody Fusion System (ALIF)
00814008020379Instrument, Trial Small, Anterior Lumbar Interbody Fusion System (ALIF)
00814008020362Instrument, Trial Small, Anterior Lumbar Interbody Fusion System (ALIF)
00814008020355Instrument, Trial Small, Anterior Lumbar Interbody Fusion System (ALIF)
00814008020348Instrument, Trial Small, Anterior Lumbar Interbody Fusion System (ALIF)
00814008020331Instrument, Trial Small, Anterior Lumbar Interbody Fusion System (ALIF)
00814008020324Instrument, Trial Small, Anterior Lumbar Interbody Fusion System (ALIF)
00814008020317Instrument, Trial Small, Anterior Lumbar Interbody Fusion System (ALIF)
00814008020300Instrument, Trial Small, Anterior Lumbar Interbody Fusion System (ALIF)
00814008020294Instrument, Tamp Curved, Anterior Lumbar Interbody Fusion System (ALIF)
00814008020287Instrument, Rasp Distractor Tip - Small, Anterior Lumbar Interbody Fusion System (ALIF)
00814008020270Instrument, Distractor Tip - Small, Anterior Lumbar Interbody Fusion System (ALIF)
00814008020263Instrument, Parallel Distractor, Anterior Lumbar Interbody Fusion System (ALIF)
00814008020256Instrument, Trans-anterior Inserter Shaft, Anterior Lumbar Interbody Fusion System (ALIF)
00814008020249Instrument, Straight Inserter, Anterior Lumbar Interbody Fusion System (ALIF)
90814008024646ALIF Encoded 29x39 20mm 12 Degree
90814008024639ALIF Encoded 29x39 18mm 12 Degree
90814008024622ALIF Encoded 29x39 16mm 12 degree
90814008024615ALIF Encoded 29x39 14mm 12 Degree
90814008024608ALIF Encoded 29x39 12mm 12 Degree
90814008024592ALIF Encoded 29x39 10mm 12 Degree
90814008024585ALIF Encoded 25x34 20mm 12 Degree
90814008024578ALIF Encoded 25x34 18mm 12 Degree
90814008024561ALIF Encoded 25x34 16mm 12 Degree
90814008024554ALIF Encoded 25x34 14mm 12 Degree
90814008024547ALIF Encoded 25x34 12mm 12 Degree
90814008024530ALIF Encoded 25x34 10mm 12 Degree
90814008024523ALIF Encoded 29x39 20mm 6 Degree

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