Zavation NanoPrime ALIF Cage

GUDID 00197157026264

NANOPrime ALIF Cage 35 X 14MM X 20°

Zavation LLC

Spinal fixation plate, non-bioabsorbable
Primary Device ID00197157026264
NIH Device Record Keya958a0cb-ebe5-407c-809d-01cec4cedc6b
Commercial Distribution StatusIn Commercial Distribution
Brand NameZavation NanoPrime ALIF Cage
Version Model Number970-2035-14
Company DUNS069472800
Company NameZavation 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 Usetrue
Lot Batchtrue
Serial Numbertrue
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

Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100197157026264 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00197157026264]

Moist Heat or Steam Sterilization


[00197157026264]

Moist Heat or Steam Sterilization


[00197157026264]

Moist Heat or Steam Sterilization


[00197157026264]

Moist Heat or Steam Sterilization


[00197157026264]

Moist Heat or Steam Sterilization


[00197157026264]

Moist Heat or Steam Sterilization


[00197157026264]

Moist Heat or Steam Sterilization


[00197157026264]

Moist Heat or Steam Sterilization


[00197157026264]

Moist Heat or Steam Sterilization


[00197157026264]

Moist Heat or Steam Sterilization


[00197157026264]

Moist Heat or Steam Sterilization


[00197157026264]

Moist Heat or Steam Sterilization


[00197157026264]

Moist Heat or Steam Sterilization


[00197157026264]

Moist Heat or Steam Sterilization


[00197157026264]

Moist Heat or Steam Sterilization


[00197157026264]

Moist Heat or Steam Sterilization


[00197157026264]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-01
Device Publish Date2024-09-23

On-Brand Devices [Zavation NanoPrime ALIF Cage]

00197157026592NANOPrime ALIF Cage 40 X 25MM X 30°
00197157026585NANOPrime ALIF Cage 40 X 23MM X 30°
00197157026578NANOPrime ALIF Cage 40 X 21MM X 30°
00197157026561NANOPrime ALIF Cage 35 X 25MM X 30°
00197157026554NANOPrime ALIF Cage 35 X 23MM X 30°
00197157026547NANOPrime ALIF Cage 35 X 21MM X 30°
00197157026530NANOPrime ALIF Cage 35 X 19MM X 30°
00197157026523NANOPrime ALIF Cage 35 X 17MM X 30°
00197157026516NANOPrime ALIF Cage 30 X 25MM X 30°
00197157026509NANOPrime ALIF Cage 30 X 23MM X 30°
00197157026493NANOPrime ALIF Cage 30 X 21MM X 30°
00197157026486NANOPrime ALIF Cage 30 X 19MM X 30°
00197157026479NANOPrime ALIF Cage 30 X 17MM X 30°
00197157026462NANOPrime ALIF Cage 30 X 15MM X 30°
00197157026455NANOPrime ALIF Cage 40 X 21MM X 25°
00197157026448NANOPrime ALIF Cage 40 X 19MM X 25°
00197157026431NANOPrime ALIF Cage 40 X 17MM X 25°
00197157026424NANOPrime ALIF Cage 35 X 21MM X 25°
00197157026417NANOPrime ALIF Cage 35 X 19MM X 25°
00197157026400NANOPrime ALIF Cage 35 X 17MM X 25°
00197157026394NANOPrime ALIF Cage 35 X 15MM X 25°
00197157026387NANOPrime ALIF Cage 30 X 21MM X 25°
00197157026370NANOPrime ALIF Cage 30 X 19MM X 25°
00197157026363NANOPrime ALIF Cage 30 X 17MM X 25°
00197157026356NANOPrime ALIF Cage 30 X 15MM X 25°
00197157026349NANOPrime ALIF Cage 40 X 21MM X 20°
00197157026332NANOPrime ALIF Cage 40 X 19MM X 20°
00197157026325NANOPrime ALIF Cage 40 X 17MM X 20°
00197157026318NANOPrime ALIF Cage 40 X 15MM X 20°
00197157026301NANOPrime ALIF Cage 35 X 21MM X 20°
00197157026295NANOPrime ALIF Cage 35 X 19MM X 20°
00197157026288NANOPrime ALIF Cage 35 X 17MM X 20°
00197157026271NANOPrime ALIF Cage 35 X 15MM X 20°
00197157026264NANOPrime ALIF Cage 35 X 14MM X 20°
00197157026257NANOPrime ALIF Cage 35 X 13MM X 20°
00197157026240NANOPrime ALIF Cage 30 X 19MM X 20°
00197157026233NANOPrime ALIF Cage 30 X 17MM X 20°
00197157026226NANOPrime ALIF Cage 30 X 15MM X 20°
00197157026219NANOPrime ALIF Cage 30 X 14MM X 20°
00197157026202NANOPrime ALIF Cage 30 X 13MM X 20°
00197157026196NANOPrime ALIF Cage 40 X 21MM X 15°
00197157026189NANOPrime ALIF Cage 40 X 19MM X 15°
00197157026172NANOPrime ALIF Cage 40 X 17MM X 15°
00197157026165NANOPrime ALIF Cage 40 X 15MM X 15°
00197157026158NANOPrime ALIF Cage 40 X 14MM X 15°
00197157026141NANOPrime ALIF Cage 40 X 13MM X 15°
00197157026134NANOPrime ALIF Cage 40 X 12MM X 15°
00197157026127NANOPrime ALIF Cage 40 X 11MM X 15°
00197157026110NANOPrime ALIF Cage 35 X 21MM X 15°
00197157026103NANOPrime ALIF Cage 35 X 19MM X 15°

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.