Zavation Modular Screw

GUDID 00842166194809

Modular Screw 8.5x110

Zavation LLC

Orthopaedic bone screw (non-sliding)
Primary Device ID00842166194809
NIH Device Record Keyd01bd286-d82f-4bda-86fb-d10ad73caaff
Commercial Distribution StatusIn Commercial Distribution
Brand NameZavation Modular Screw
Version Model Number383-85110-S
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
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
GS100842166194809 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00842166194809]

Moist Heat or Steam Sterilization

[00842166194809]

Moist Heat or Steam Sterilization

[00842166194809]

Moist Heat or Steam Sterilization

[00842166194809]

Moist Heat or Steam Sterilization

[00842166194809]

Moist Heat or Steam Sterilization

[00842166194809]

Moist Heat or Steam Sterilization

[00842166194809]

Moist Heat or Steam Sterilization

[00842166194809]

Moist Heat or Steam Sterilization

[00842166194809]

Moist Heat or Steam Sterilization

[00842166194809]

Moist Heat or Steam Sterilization

[00842166194809]

Moist Heat or Steam Sterilization

[00842166194809]

Moist Heat or Steam Sterilization

[00842166194809]

Moist Heat or Steam Sterilization

[00842166194809]

Moist Heat or Steam Sterilization

[00842166194809]

Moist Heat or Steam Sterilization

[00842166194809]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-20
Device Publish Date2024-11-12

Devices Manufactured by Zavation LLC

00197157016791 - ZAVATION ROD CONNECTOR2025-06-13 ROD CONNECTOR, PARALLEL TOP LOADING 14mm offset,5.5/6.0mm X 5.5/6.0mm
00197157016807 - ZAVATION ROD CONNECTOR2025-06-13 ROD CONNECTOR, PARALLEL TOP LOADING 10° offset,5.5/6.0mm X 5.5/6.0mm
00197157016814 - ZAVATION ROD CONNECTOR2025-06-13 ROD CONNECTOR, PARALLEL TOP LOADING 20°offset,5.5/6.0mm X 5.5/6.0mm
00197157016821 - ZAVATION ROD CONNECTOR2025-06-13 ROD CONNECTOR, PARALLEL TOP LOADING 30°offset,5.5/6.0mm X 5.5/6.0mm
00197157016838 - ZAVATION ROD CONNECTOR2025-06-13 ROD CONNECTOR, AXIAL CLOSED mm offset,3.5/4.0mm X 4.75/5.5mm
00197157016845 - ZAVATION ROD CONNECTOR2025-06-13 ROD CONNECTOR, AXIAL CLOSED mm offset,3.5/4.0mm X 5.5/6.0mm
00197157016852 - ZAVATION ROD CONNECTOR2025-06-13 ROD CONNECTOR, AXIAL CLOSED mm offset,4.75/5.5mm X 4.75/5.5mm
00197157016869 - ZAVATION ROD CONNECTOR2025-06-13 ROD CONNECTOR, AXIAL CLOSED mm offset,4.75/5.5mm X 5.5/6.0mm
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