ZAVATION ROD

GUDID 00197157071707

5509 SERIES STRAIGHT ROD MIS, COBALT CHROME

Zavation LLC

Orthopaedic bone pin, non-bioabsorbable
Primary Device ID00197157071707
NIH Device Record Key1cc7d032-1710-453d-a9e5-f1a449e32509
Commercial Distribution StatusIn Commercial Distribution
Brand NameZAVATION ROD
Version Model NumberR5509-095
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 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
GS100197157071707 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00197157071707]

Moist Heat or Steam Sterilization


[00197157071707]

Moist Heat or Steam Sterilization


[00197157071707]

Moist Heat or Steam Sterilization


[00197157071707]

Moist Heat or Steam Sterilization


[00197157071707]

Moist Heat or Steam Sterilization


[00197157071707]

Moist Heat or Steam Sterilization


[00197157071707]

Moist Heat or Steam Sterilization


[00197157071707]

Moist Heat or Steam Sterilization


[00197157071707]

Moist Heat or Steam Sterilization


[00197157071707]

Moist Heat or Steam Sterilization


[00197157071707]

Moist Heat or Steam Sterilization


[00197157071707]

Moist Heat or Steam Sterilization


[00197157071707]

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]

00197157015053TIGER 2, CADDY, Ø 5.5MM
001971570718135509 SERIES STRAIGHT ROD MIS, COBALT CHROME
001971570718065509 SERIES STRAIGHT ROD MIS, COBALT CHROME
001971570717905509 SERIES STRAIGHT ROD MIS, COBALT CHROME
001971570717835509 SERIES STRAIGHT ROD MIS, COBALT CHROME
001971570717695509 SERIES STRAIGHT ROD MIS, COBALT CHROME
001971570717525509 SERIES STRAIGHT ROD MIS, COBALT CHROME
001971570717455509 SERIES STRAIGHT ROD MIS, COBALT CHROME
001971570717385509 SERIES STRAIGHT ROD MIS, COBALT CHROME "
001971570717215509 SERIES STRAIGHT ROD MIS, COBALT CHROME
00197157071714"5509 SERIES STRAIGHT ROD MIS, COBALT CHROME "
001971570717075509 SERIES STRAIGHT ROD MIS, COBALT CHROME
001971570716915509 SERIES STRAIGHT ROD MIS, COBALT CHROME
001971570716845509 SERIES STRAIGHT ROD MIS, COBALT CHROME
001971570716775509 SERIES STRAIGHT ROD MIS, COBALT CHROME
001971570716605509 SERIES STRAIGHT ROD MIS, COBALT CHROME
001971570716535509 SERIES STRAIGHT ROD MIS, COBALT CHROME
001971570716465509 SERIES STRAIGHT ROD MIS, COBALT CHROME
001971570716395509 SERIES STRAIGHT ROD MIS, COBALT CHROME
00197157071622"5509 SERIES STRAIGHT ROD MIS, COBALT CHROME "
001971570716155509 SERIES STRAIGHT ROD MIS, COBALT CHROME
001971570716085509 SERIES STRAIGHT ROD MIS, COBALT CHROME
001971570715925509 SERIES STRAIGHT ROD MIS, COBALT CHROME
001971570715855509 SERIES STRAIGHT ROD MIS, COBALT CHROME

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