Zavation Deformity Polyaxial Screw

GUDID 00197157041847

Fenestrated Cortical-Cancellous Threaded Screw 5.5 x 35

Zavation LLC

Orthopaedic bone screw (non-sliding)
Primary Device ID00197157041847
NIH Device Record Key1d50d429-270e-4b27-a4a4-6231b6d40466
Commercial Distribution StatusIn Commercial Distribution
Brand NameZavation Deformity Polyaxial Screw
Version Model Number1011-C-5535-F
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
GS100197157041847 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00197157041847]

Moist Heat or Steam Sterilization

[00197157041847]

Moist Heat or Steam Sterilization

[00197157041847]

Moist Heat or Steam Sterilization

[00197157041847]

Moist Heat or Steam Sterilization

[00197157041847]

Moist Heat or Steam Sterilization

[00197157041847]

Moist Heat or Steam Sterilization

[00197157041847]

Moist Heat or Steam Sterilization

[00197157041847]

Moist Heat or Steam Sterilization

[00197157041847]

Moist Heat or Steam Sterilization

[00197157041847]

Moist Heat or Steam Sterilization

[00197157041847]

Moist Heat or Steam Sterilization

[00197157041847]

Moist Heat or Steam Sterilization

[00197157041847]

Moist Heat or Steam Sterilization

[00197157041847]

Moist Heat or Steam Sterilization

[00197157041847]

Moist Heat or Steam Sterilization

[00197157041847]

Moist Heat or Steam Sterilization

[00197157041847]

Moist Heat or Steam Sterilization

[00197157041847]

Moist Heat or Steam Sterilization

[00197157041847]

Moist Heat or Steam Sterilization

[00197157041847]

Moist Heat or Steam Sterilization

[00197157041847]

Moist Heat or Steam Sterilization

[00197157041847]

Moist Heat or Steam Sterilization

[00197157041847]

Moist Heat or Steam Sterilization

[00197157041847]

Moist Heat or Steam Sterilization

[00197157041847]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-30
Device Publish Date2024-10-22

On-Brand Devices [Zavation Deformity Polyaxial Screw]

00197157029876Cannulated Cortical - Cancellous Threaded Screw 4.5 x 30
00197157029869Cannulated Cortical - Cancellous Threaded Screw 4.5 x 25
00197157030957Cannulated Cortical-Cancellous Threaded Screw 10.5 x 30
00197157030940Cannulated Cortical-Cancellous Threaded Screw 10.5 x 25
00197157030933Cannulated Cortical-Cancellous Threaded Screw 9.5 x 110
00197157030926Cannulated Cortical-Cancellous Threaded Screw 9.5 x 105
00197157030919Cannulated Cortical-Cancellous Threaded Screw 9.5 x 100
00197157030902Cannulated Cortical-Cancellous Threaded Screw 9.5 x 95
00197157030896Cannulated Cortical-Cancellous Threaded Screw 9.5 x 90
00197157030889Cannulated Cortical-Cancellous Threaded Screw 9.5 x 85
00197157030872Cannulated Cortical-Cancellous Threaded Screw 9.5 x 80
00197157030865Cannulated Cortical-Cancellous Threaded Screw 9.5 x 75
00197157030858Cannulated Cortical-Cancellous Threaded Screw 9.5 x 70
00197157030841Cannulated Cortical-Cancellous Threaded Screw 9.5 x 65
00197157030834Cannulated Cortical-Cancellous Threaded Screw 9.5 x 60
00197157030827Cannulated Cortical-Cancellous Threaded Screw 9.5 x 55
00197157030810Cannulated Cortical-Cancellous Threaded Screw 9.5 x 50
00197157030803Cannulated Cortical-Cancellous Threaded Screw 9.5 x 45
00197157030797Cannulated Cortical-Cancellous Threaded Screw 9.5 x 40
00197157030780Cannulated Cortical-Cancellous Threaded Screw 9.5 x 35
00197157030773Cannulated Cortical-Cancellous Threaded Screw 9.5 x 30
00197157030766Cannulated Cortical-Cancellous Threaded Screw 9.5 x 25
00197157030759Cannulated Cortical-Cancellous Threaded Screw 8.5 x 110
00197157030742Cannulated Cortical-Cancellous Threaded Screw 8.5 x 105
00197157030735Cannulated Cortical-Cancellous Threaded Screw 8.5 x 100
00197157030728Cannulated Cortical-Cancellous Threaded Screw 8.5 x 95
00197157030711Cannulated Cortical-Cancellous Threaded Screw 8.5 x 90
00197157030704Cannulated Cortical-Cancellous Threaded Screw 8.5 x 85
00197157030698Cannulated Cortical-Cancellous Threaded Screw 8.5 x 80
00197157030681Cannulated Cortical-Cancellous Threaded Screw 8.5 x 75
00197157030674Cannulated Cortical-Cancellous Threaded Screw 8.5 x 70
00197157030667Cannulated Cortical-Cancellous Threaded Screw 8.5 x 65
00197157030650Cannulated Cortical-Cancellous Threaded Screw 8.5 x 60
00197157030643Cannulated Cortical-Cancellous Threaded Screw 8.5 x 55
00197157030636Cannulated Cortical-Cancellous Threaded Screw 8.5 x 50
00197157030629Cannulated Cortical-Cancellous Threaded Screw 8.5 x 45
00197157030612Cannulated Cortical-Cancellous Threaded Screw 8.5 x 40
00197157030605Cannulated Cortical-Cancellous Threaded Screw 8.5 x 35
00197157030599Cannulated Cortical-Cancellous Threaded Screw 8.5 x 30
00197157030582Cannulated Cortical-Cancellous Threaded Screw 8.5 x 25
00197157030575Cannulated Cortical-Cancellous Threaded Screw 7.5 x 110
00197157030568Cannulated Cortical-Cancellous Threaded Screw 7.5 x 105
00197157030551Cannulated Cortical-Cancellous Threaded Screw 7.5 x 100
00197157030544Cannulated Cortical-Cancellous Threaded Screw 7.5 x 95
00197157030537Cannulated Cortical-Cancellous Threaded Screw 7.5 x 90
00197157030520Cannulated Cortical-Cancellous Threaded Screw 7.5 x 85
00197157030513Cannulated Cortical-Cancellous Threaded Screw 7.5 x 80
00197157030506Cannulated Cortical-Cancellous Threaded Screw 7.5 x 75
00197157030490Cannulated Cortical-Cancellous Threaded Screw 7.5 x 70
00197157030483Cannulated Cortical-Cancellous Threaded Screw 7.5 x 65
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.