ZAVATION ROD BENDER

GUDID 00197157071417

INSITU BENDER - LEFT 6.0 ROD

Zavation LLC

Manual orthopaedic bender, reusable
Primary Device ID00197157071417
NIH Device Record Keycb010029-3471-4b80-bf0d-4e8dd0e8bedd
Commercial Distribution StatusIn Commercial Distribution
Brand NameZAVATION ROD BENDER
Version Model Number989-1065-L
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
Phone6019191119
Emailinfo@zavation.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100197157071417 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00197157071417]

Moist Heat or Steam Sterilization


[00197157071417]

Moist Heat or Steam Sterilization


[00197157071417]

Moist Heat or Steam Sterilization


[00197157071417]

Moist Heat or Steam Sterilization


[00197157071417]

Moist Heat or Steam Sterilization


[00197157071417]

Moist Heat or Steam Sterilization


[00197157071417]

Moist Heat or Steam Sterilization


[00197157071417]

Moist Heat or Steam Sterilization


[00197157071417]

Moist Heat or Steam Sterilization


[00197157071417]

Moist Heat or Steam Sterilization


[00197157071417]

Moist Heat or Steam Sterilization


[00197157071417]

Moist Heat or Steam Sterilization


[00197157071417]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-23
Device Publish Date2025-09-15

On-Brand Devices [ZAVATION ROD BENDER]

00197157071417INSITU BENDER - LEFT 6.0 ROD
00197157071400INSITU BENDER - RIGHT 6.0 ROD

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