ZAVATION ROD CONNECTOR

GUDID 00197157016814

ROD CONNECTOR, PARALLEL TOP LOADING 20°offset,5.5/6.0mm X 5.5/6.0mm

Zavation LLC

Bone-screw internal spinal fixation system connector
Primary Device ID00197157016814
NIH Device Record Key678d7f09-fa87-4c76-93c6-12429b2d5742
Commercial Distribution StatusIn Commercial Distribution
Brand NameZAVATION ROD CONNECTOR
Version Model Number880-3320
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
Phone6019191119
Emailinfo@zavation.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100197157016814 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00197157016814]

Moist Heat or Steam Sterilization

[00197157016814]

Moist Heat or Steam Sterilization

[00197157016814]

Moist Heat or Steam Sterilization

[00197157016814]

Moist Heat or Steam Sterilization

[00197157016814]

Moist Heat or Steam Sterilization

[00197157016814]

Moist Heat or Steam Sterilization

[00197157016814]

Moist Heat or Steam Sterilization

[00197157016814]

Moist Heat or Steam Sterilization

[00197157016814]

Moist Heat or Steam Sterilization

[00197157016814]

Moist Heat or Steam Sterilization

[00197157016814]

Moist Heat or Steam Sterilization

[00197157016814]

Moist Heat or Steam Sterilization

[00197157016814]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-13
Device Publish Date2025-06-05

On-Brand Devices [ZAVATION ROD CONNECTOR]

00197157016784ROD CONNECTOR, PARALLEL TOP LOADING 12mm offset,5.5/6.0mm X 5.5/6.0mm
00197157016777ROD CONNECTOR, PARALLEL TOP LOADING 10mm offset,5.5/6.0mm X 5.5/6.0mm
00197157016760ROD CONNECTOR, PARALLEL SIDE LOADING 18mm offset,3.5/4.0mm X 3.5/4.0mm
00197157016753ROD CONNECTOR, PARALLEL SIDE LOADING 16mm offset,3.5/4.0mm X 3.5/4.0mm
00197157016746ROD CONNECTOR, PARALLEL SIDE LOADING 14mm offset,3.5/4.0mm X 3.5/4.0mm
00197157016739ROD CONNECTOR, PARALLEL SIDE LOADING 12mm offset,3.5/4.0mm X 3.5/4.0mm
00197157016722ROD CONNECTOR, PARALLEL SIDE LOADING 10mm offset,3.5/4.0mm X 3.5/4.0mm
00197157016715ROD CONNECTOR, PARALLEL SIDE LOADING 14mm offset,5.5/6.0mm X 3.5/4.0mm
00197157016708ROD CONNECTOR, PARALLEL SIDE LOADING 10mm offset,5.5/6.0mm X 3.5/4.0mm
00197157016692ROD CONNECTOR, PARALLEL SIDE LOADING 14mm offset,4.75/5.5mm X 3.5/4.0mm
00197157016685ROD CONNECTOR, PARALLEL SIDE LOADING 10mm offset,4.75/5.5mm X 3.5/4.0mm
00197157016678ROD CONNECTOR, PARALLEL SIDE LOADING 14mm offset,5.5/6.0mm X 5.5/6.0mm
00197157016661ROD CONNECTOR, PARALLEL SIDE LOADING 10mm offset,5.5/6.0mm X 5.5/6.0mm
00197157016654ROD CONNECTOR, PARALLEL SIDE LOADING 14mm offset,5.5/6.0mm X 4.75/5.5mm
00197157016647ROD CONNECTOR, PARALLEL SIDE LOADING 10mm offset,5.5/6.0mm X 4.75/5.5mm
00197157016630ROD CONNECTOR, PARALLEL SIDE LOADING 14mm offset,4.75/5.5mm X 4.75/5.5mm
00197157016623ROD CONNECTOR, PARALLEL SIDE LOADING 10mm offset,4.75/5.5mm X 4.75/5.5mm
00197157016616ROD CONNECTOR, PARALLEL SIDE LOADING/CLOSED 18mm offset,5.5/6.0mm X 3.5/4.0mm
00197157016609ROD CONNECTOR, PARALLEL SIDE LOADING/CLOSED 16mm offset,5.5/6.0mm X 3.5/4.0mm
00197157016593ROD CONNECTOR, PARALLEL SIDE LOADING/CLOSED 14mm offset,5.5/6.0mm X 3.5/4.0mm
00197157016586ROD CONNECTOR, PARALLEL SIDE LOADING/CLOSED 12mm offset,5.5/6.0mm X 3.5/4.0mm
00197157016579ROD CONNECTOR, PARALLEL SIDE LOADING/CLOSED 10mm offset,5.5/6.0mm X 3.5/4.0mm
00197157016562ROD CONNECTOR, PARALLEL SIDE LOADING/CLOSED 18mm offset,3.5/4.0mm X 3.5/4.0mm
00197157016555ROD CONNECTOR, PARALLEL SIDE LOADING/CLOSED 16mm offset,3.5/4.0mm X 3.5/4.0mm
00197157016548ROD CONNECTOR, PARALLEL SIDE LOADING/CLOSED 14mm offset,3.5/4.0mm X 3.5/4.0mm
00197157016531ROD CONNECTOR, PARALLEL SIDE LOADING/CLOSED 12mm offset,3.5/4.0mm X 3.5/4.0mm
00197157016524ROD CONNECTOR, PARALLEL SIDE LOADING/CLOSED 10mm offset,3.5/4.0mm X 3.5/4.0mm
00197157016517ROD CONNECTOR, PARALLEL SIDE LOADING/CLOSED 18mm offset,4.75/5.5mm X 3.5/4.0mm
00197157016500ROD CONNECTOR, PARALLEL SIDE LOADING/CLOSED 16mm offset,4.75/5.5mm X 3.5/4.0mm
00197157016494ROD CONNECTOR, PARALLEL SIDE LOADING/CLOSED 14mm offset,4.75/5.5mm X 3.5/4.0mm
00197157016487ROD CONNECTOR, PARALLEL SIDE LOADING/CLOSED 12mm offset,4.75/5.5mm X 3.5/4.0mm
00197157016470ROD CONNECTOR, PARALLEL SIDE LOADING/CLOSED 10mm offset,4.75/5.5mm X 3.5/4.0mm
00197157016463ROD CONNECTOR, PARALLEL SIDE LOADING/CLOSED 18mm offset,5.5/6.0mm X 5.5/6.0mm
00197157016456ROD CONNECTOR, PARALLEL SIDE LOADING/CLOSED 16mm offset,5.5/6.0mm X 5.5/6.0mm
00197157016449ROD CONNECTOR, PARALLEL SIDE LOADING/CLOSED 14mm offset,5.5/6.0mm X 5.5/6.0mm
00197157016432ROD CONNECTOR, PARALLEL SIDE LOADING/CLOSED 12mm offset,5.5/6.0mm X 5.5/6.0mm
00197157016425ROD CONNECTOR, PARALLEL SIDE LOADING/CLOSED 10mm offset,5.5/6.0mm X 5.5/6.0mm
00197157016418ROD CONNECTOR, PARALLEL SIDE LOADING/CLOSED 18mm offset,5.5/6.0mm X 4.75/5.5mm
00197157016401ROD CONNECTOR, PARALLEL SIDE LOADING/CLOSED 16mm offset,5.5/6.0mm X 4.75/5.5mm
00197157016395ROD CONNECTOR, PARALLEL SIDE LOADING/CLOSED 14mm offset,5.5/6.0mm X 4.75/5.5mm
00197157016388ROD CONNECTOR, PARALLEL SIDE LOADING/CLOSED 12mm offset,5.5/6.0mm X 4.75/5.5mm
00197157016371ROD CONNECTOR, PARALLEL SIDE LOADING/CLOSED 10mm offset,5.5/6.0mm X 4.75/5.5mm
00197157016364ROD CONNECTOR, PARALLEL SIDE LOADING/CLOSED 18mm offset,4.75/5.5mm X 4.75/5.5mm
00197157016357ROD CONNECTOR, PARALLEL SIDE LOADING/CLOSED 16mm offset,4.75/5.5mm X 4.75/5.5mm
00197157016340ROD CONNECTOR, PARALLEL SIDE LOADING/CLOSED 14mm offset,4.75/5.5mm X 4.75/5.5mm
00197157016333ROD CONNECTOR, PARALLEL SIDE LOADING/CLOSED 12mm offset,4.75/5.5mm X 4.75/5.5mm
00197157016326ROD CONNECTOR, PARALLEL SIDE LOADING/CLOSED 10mm offset,4.75/5.5mm X 4.75/5.5mm
00197157016319ROD CONNECTOR, PARALLEL CLOSED 18mm OFFSET, Ø 3.5 X 3.5mm
00197157016302ROD CONNECTOR, PARALLEL CLOSED 16mm OFFSET, Ø 3.5 X 3.5mm
00197157016296ROD CONNECTOR, PARALLEL CLOSED 14mm OFFSET, Ø 3.5 X 3.5mm
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.