Anatomic PEEK™ Cervical Fusion System with Nanotechnology 6208786

GUDID 00814216026590

Anatomic PEEK Trial, 7 x 18 x 16 x 10°

NANOVIS SPINE, LLC

Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage
Primary Device ID00814216026590
NIH Device Record Key2ff886e2-5230-4a56-aa57-e72cae2de17f
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnatomic PEEK™ Cervical Fusion System with Nanotechnology
Version Model Number6208786
Catalog Number6208786
Company DUNS079898044
Company NameNANOVIS SPINE, LLC
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 Usefalse
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

Phone8779076266
Emailnanovisquality@nanovistechnology.com
Phone8779076266
Emailnanovisquality@nanovistechnology.com
Phone8779076266
Emailnanovisquality@nanovistechnology.com
Phone8779076266
Emailnanovisquality@nanovistechnology.com
Phone8779076266
Emailnanovisquality@nanovistechnology.com
Phone8779076266
Emailnanovisquality@nanovistechnology.com
Phone8779076266
Emailnanovisquality@nanovistechnology.com
Phone8779076266
Emailnanovisquality@nanovistechnology.com
Phone8779076266
Emailnanovisquality@nanovistechnology.com
Phone8779076266
Emailnanovisquality@nanovistechnology.com
Phone8779076266
Emailnanovisquality@nanovistechnology.com
Phone8779076266
Emailnanovisquality@nanovistechnology.com
Phone8779076266
Emailnanovisquality@nanovistechnology.com
Phone8779076266
Emailnanovisquality@nanovistechnology.com
Phone8779076266
Emailnanovisquality@nanovistechnology.com
Phone8779076266
Emailnanovisquality@nanovistechnology.com
Phone8779076266
Emailnanovisquality@nanovistechnology.com

Device Dimensions

Length7 Millimeter
Width18 Millimeter
Height16 Millimeter
Length7 Millimeter
Width18 Millimeter
Height16 Millimeter
Length7 Millimeter
Width18 Millimeter
Height16 Millimeter
Length7 Millimeter
Width18 Millimeter
Height16 Millimeter
Length7 Millimeter
Width18 Millimeter
Height16 Millimeter
Length7 Millimeter
Width18 Millimeter
Height16 Millimeter
Length7 Millimeter
Width18 Millimeter
Height16 Millimeter
Length7 Millimeter
Width18 Millimeter
Height16 Millimeter
Length7 Millimeter
Width18 Millimeter
Height16 Millimeter
Length7 Millimeter
Width18 Millimeter
Height16 Millimeter
Length7 Millimeter
Width18 Millimeter
Height16 Millimeter
Length7 Millimeter
Width18 Millimeter
Height16 Millimeter
Length7 Millimeter
Width18 Millimeter
Height16 Millimeter
Length7 Millimeter
Width18 Millimeter
Height16 Millimeter
Length7 Millimeter
Width18 Millimeter
Height16 Millimeter
Length7 Millimeter
Width18 Millimeter
Height16 Millimeter
Length7 Millimeter
Width18 Millimeter
Height16 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100814216026590 [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

[00814216026590]

Moist Heat or Steam Sterilization

[00814216026590]

Moist Heat or Steam Sterilization

[00814216026590]

Moist Heat or Steam Sterilization

[00814216026590]

Moist Heat or Steam Sterilization

[00814216026590]

Moist Heat or Steam Sterilization

[00814216026590]

Moist Heat or Steam Sterilization

[00814216026590]

Moist Heat or Steam Sterilization

[00814216026590]

Moist Heat or Steam Sterilization

[00814216026590]

Moist Heat or Steam Sterilization

[00814216026590]

Moist Heat or Steam Sterilization

[00814216026590]

Moist Heat or Steam Sterilization

[00814216026590]

Moist Heat or Steam Sterilization

[00814216026590]

Moist Heat or Steam Sterilization

[00814216026590]

Moist Heat or Steam Sterilization

[00814216026590]

Moist Heat or Steam Sterilization

[00814216026590]

Moist Heat or Steam Sterilization

[00814216026590]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-03
Device Publish Date2023-09-25

On-Brand Devices [Anatomic PEEK™ Cervical Fusion System with Nanotechnology]

00814216027887ANATOMIC PEEK w/ Nano 14 x 11 x 5 x 10°
00814216028235ANATOMIC PEEK w/ Nano 18 x 16 x 10 x 4.6°
00814216028228ANATOMIC PEEK w/ Nano 18 x 16 x 9 x 4.6°
00814216028211ANATOMIC PEEK w/ Nano 18 x 16 x 8 x 4.6°
00814216028204ANATOMIC PEEK w/ Nano 18 x 16 x 7 x 4.6°
00814216028198ANATOMIC PEEK w/ Nano 18 x 16 x 6 x 4.6°
00814216028181ANATOMIC PEEK w/ Nano 18 x 16 x 5 x 4.6°
00814216028174ANATOMIC PEEK w/ Nano 16 x 14 x 10 x 4.6°
00814216028167ANATOMIC PEEK w/ Nano 16 x 14 x 9 x 4.6°
00814216028150ANATOMIC PEEK w/ Nano 16 x 14 x 8 x 4.6°
00814216028143ANATOMIC PEEK w/ Nano 16 x 14 x 7 x 4.6°
00814216028136ANATOMIC PEEK w/ Nano 16 x 14 x 6 x 4.6°
00814216028129ANATOMIC PEEK w/ Nano 16 x 14 x 5 x 4.6°
00814216028112ANATOMIC PEEK w/ Nano 14x11x10x4.6°
00814216028105ANATOMIC PEEK w/ Nano 14x11x9x4.6°
00814216028099ANATOMIC PEEK w/ Nano 14x11x8x4.6°
00814216028082ANATOMIC PEEK w/ Nano 14x11x7x4.6°
00814216028075ANATOMIC PEEK w/ Nano 14x11x6x4.6°
00814216028068ANATOMIC PEEK w/ Nano 14x11x5x4.6°
00814216028051ANATOMIC PEEK w/ Nano 18 x 16 x 10 x 10°
00814216028044ANATOMIC PEEK w/ Nano 18 x 16 x 9 x 10°
00814216028037ANATOMIC PEEK w/ Nano 18 x 16 x 8 x 10°
00814216028020ANATOMIC PEEK w/ Nano 18 x 16 x 6 x 10°
00814216028013ANATOMIC PEEK w/ Nano 18 x 16 x 6 x 10°
00814216028006ANATOMIC PEEK w/ Nano 18 x 16 x 5 x 10°
00814216027993ANATOMIC PEEK w/ Nano 16 x 14 x 10 x 10°
00814216027986ANATOMIC PEEK w/ Nano 16 x 14 x 9 x 10°
00814216027979ANATOMIC PEEK w/ Nano 16 x 14 x 8 x 10°
00814216027962ANATOMIC PEEK w/ Nano 16 x 14 x 7 x 10°
00814216027955ANATOMIC PEEK w/ Nano 16 x 14 x 6 x 10°
00814216027948ANATOMIC PEEK w/ Nano 16 x 14 x 5 x 10°
00814216027931ANATOMIC PEEK w/ Nano 14 x 11 x 10 x 10°
00814216027924ANATOMIC PEEK w/ Nano 14 x 11 x 9 x 10°
00814216027917ANATOMIC PEEK w/ Nano 14 x 11 x 8 x 10°
00814216027900ANATOMIC PEEK w/ Nano 14 x 11 x 7 x 10°
00814216027894ANATOMIC PEEK w/ Nano 14 x 11 x 6 x 10°
00814216026620Anatomic PEEK Trial, 10 x 18 x 16 x 10°
00814216026613Anatomic PEEK Trial, 9 x 18 x 16 x 10°
00814216026606Anatomic PEEK Trial, 8 x 18 x 16 x 10°
00814216026590Anatomic PEEK Trial, 7 x 18 x 16 x 10°
00814216026583Anatomic PEEK Trial, 6 x 18 x 16 x 10°
00814216026576Anatomic PEEK Trial, 5 x 18 x 16 x 10°
00814216026569Anatomic PEEK Trial, 10 x 16 x 14 x 10°
00814216026552Anatomic PEEK Trial, 9 x 16 x 14 x 10°
00814216026545Anatomic PEEK Trial, 8 x 16 x 14 x 10°
00814216026538Anatomic PEEK Trial, 7 x 16 x 14 x 10°
00814216026521Anatomic PEEK Trial, 6 x 16 x 14 x 10°
00814216026491Anatomic PEEK Trial, 5 x 16 x 14 x 10°
00814216026484Anatomic PEEK Trial, 10 x 14 x 11 x 10°
00814216026477Anatomic PEEK Trial, 9 x 14 x 11 x 10°
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.