ZAVATION ALIF SIZER

GUDID 00197157069919

ALIF SIZER

Zavation LLC

Surgical implant/trial-implant/sizer holder, reusable
Primary Device ID00197157069919
NIH Device Record Keydc192b99-03ca-44ee-95f2-7915f8e382f1
Commercial Distribution StatusIn Commercial Distribution
Brand NameZAVATION ALIF SIZER
Version Model Number869-1051-1530-11-R
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 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

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
GS100197157069919 [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

[00197157069919]

Moist Heat or Steam Sterilization


[00197157069919]

Moist Heat or Steam Sterilization


[00197157069919]

Moist Heat or Steam Sterilization


[00197157069919]

Moist Heat or Steam Sterilization


[00197157069919]

Moist Heat or Steam Sterilization


[00197157069919]

Moist Heat or Steam Sterilization


[00197157069919]

Moist Heat or Steam Sterilization


[00197157069919]

Moist Heat or Steam Sterilization


[00197157069919]

Moist Heat or Steam Sterilization


[00197157069919]

Moist Heat or Steam Sterilization


[00197157069919]

Moist Heat or Steam Sterilization


[00197157069919]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-11
Device Publish Date2025-09-03

On-Brand Devices [ZAVATION ALIF SIZER]

00197157069797ALIF SIZER
00197157069780ALIF SIZER
00197157069773ALIF SIZER
00197157069766ALIF SIZER
00197157069759ALIF SIZER
00197157069742ALIF SIZER
00197157069735ALIF SIZER
00197157069711ALIF SIZER
00197157069704ALIF SIZER
00197157069698ALIF SIZER
00197157069681ALIF SIZER
00197157069674ALIF SIZER
00197157070212ALIF SIZER
00197157070205ALIF SIZER
00197157070199ALIF SIZER
00197157070182ALIF SIZER
00197157070175ALIF SIZER
00197157070168ALIF SIZER
00197157070151ALIF SIZER
00197157070144ALIF SIZER
00197157070137ALIF SIZER
00197157070120ALIF SIZER
00197157070113ALIF SIZER
00197157070106ALIF SIZER
00197157070090ALIF SIZER
00197157070083ALIF SIZER
00197157070076ALIF SIZER
00197157070069ALIF SIZER
00197157070052ALIF SIZER
00197157070045ALIF SIZER
00197157070038ALIF SIZER
00197157070021ALIF SIZER
00197157070014ALIF SIZER
00197157070007ALIF SIZER
00197157069995ALIF SIZER
00197157069988ALIF SIZER
00197157069971ALIF SIZER
00197157069964ALIF SIZER
00197157069957ALIF SIZER
00197157069940ALIF SIZER
00197157069933ALIF SIZER
00197157069926ALIF SIZER
00197157069919ALIF SIZER
00197157069902ALIF SIZER
00197157069896ALIF SIZER
00197157069889ALIF SIZER
00197157069872ALIF SIZER
00197157069865ALIF SIZER
00197157069858ALIF SIZER
00197157069841ALIF SIZER

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