Zavation Deformity Polpaxial Screw

GUDID 00197157029890

Cannulated Cortical-Cancellous Threaded Screw 4.5 x 40

Zavation LLC

Orthopaedic bone screw (non-sliding)
Primary Device ID00197157029890
NIH Device Record Keyacceeca7-2551-47ca-af69-41b6ff14d614
Commercial Distribution StatusIn Commercial Distribution
Brand NameZavation Deformity Polpaxial Screw
Version Model Number1010-C-4540-C
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
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100197157029890 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00197157029890]

Moist Heat or Steam Sterilization

[00197157029890]

Moist Heat or Steam Sterilization

[00197157029890]

Moist Heat or Steam Sterilization

[00197157029890]

Moist Heat or Steam Sterilization

[00197157029890]

Moist Heat or Steam Sterilization

[00197157029890]

Moist Heat or Steam Sterilization

[00197157029890]

Moist Heat or Steam Sterilization

[00197157029890]

Moist Heat or Steam Sterilization

[00197157029890]

Moist Heat or Steam Sterilization

[00197157029890]

Moist Heat or Steam Sterilization

[00197157029890]

Moist Heat or Steam Sterilization

[00197157029890]

Moist Heat or Steam Sterilization

[00197157029890]

Moist Heat or Steam Sterilization

[00197157029890]

Moist Heat or Steam Sterilization

[00197157029890]

Moist Heat or Steam Sterilization

[00197157029890]

Moist Heat or Steam Sterilization

[00197157029890]

Moist Heat or Steam Sterilization

[00197157029890]

Moist Heat or Steam Sterilization

[00197157029890]

Moist Heat or Steam Sterilization

[00197157029890]

Moist Heat or Steam Sterilization

[00197157029890]

Moist Heat or Steam Sterilization

[00197157029890]

Moist Heat or Steam Sterilization

[00197157029890]

Moist Heat or Steam Sterilization

[00197157029890]

Moist Heat or Steam Sterilization

[00197157029890]

Moist Heat or Steam Sterilization

[00197157029890]

Moist Heat or Steam Sterilization

[00197157029890]

Moist Heat or Steam Sterilization

[00197157029890]

Moist Heat or Steam Sterilization

[00197157029890]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-02
Device Publish Date2024-09-24

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00197157049881 - Zavation INSERTER OUTTER SHAFT2025-01-21 INSERTER OUTTER SHAFT
00197157049898 - Zavation INSERTER INNER SHAFT2025-01-21 INSERTER INNER SHAFT
00197157049904 - Zavation STRAIGHT ROD2025-01-21 STRAIGHT ROD
00197157049911 - Zavation STRAIGHT ROD2025-01-21 STRAIGHT ROD
00197157049928 - Zavation CUSTOM DRILL GUIDE2025-01-21 CUSTOM DRILL GUIDE
00197157049935 - Zavation CUSTOM CERVICAL DRILL2025-01-21 CUSTOM CERVICAL DRILL
00197157049942 - Zavation CERVICAL SPLIT DRIVER2025-01-21 2.5mm CERVICAL SPLIT DRIVER
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