Zavation Deformity Polyaxial Screw

GUDID 00197157046392

Fenestrated Standard Threaded Screw 10.5 x 60

Zavation LLC

Orthopaedic bone screw (non-sliding)

• Primary Device ID: 00197157046392
• NIH Device Record Key: 09a309f4-8df7-4647-9462-ed144cf2ae5a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zavation Deformity Polyaxial Screw
• Version Model Number: 1011-S-10560-F
• Company DUNS: 069472800
• Company Name: Zavation LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00197157046392 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222614

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00197157046392]

Moist Heat or Steam Sterilization

[00197157046392]

Moist Heat or Steam Sterilization

[00197157046392]

Moist Heat or Steam Sterilization

[00197157046392]

Moist Heat or Steam Sterilization

[00197157046392]

Moist Heat or Steam Sterilization

[00197157046392]

Moist Heat or Steam Sterilization

[00197157046392]

Moist Heat or Steam Sterilization

[00197157046392]

Moist Heat or Steam Sterilization

[00197157046392]

Moist Heat or Steam Sterilization

[00197157046392]

Moist Heat or Steam Sterilization

[00197157046392]

Moist Heat or Steam Sterilization

[00197157046392]

Moist Heat or Steam Sterilization

[00197157046392]

Moist Heat or Steam Sterilization

[00197157046392]

Moist Heat or Steam Sterilization

[00197157046392]

Moist Heat or Steam Sterilization

[00197157046392]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-04
• Device Publish Date: 2024-10-25

On-Brand Devices [Zavation Deformity Polyaxial Screw]

• 00197157029876: Cannulated Cortical - Cancellous Threaded Screw 4.5 x 30
• 00197157029869: Cannulated Cortical - Cancellous Threaded Screw 4.5 x 25
• 00197157030957: Cannulated Cortical-Cancellous Threaded Screw 10.5 x 30
• 00197157030940: Cannulated Cortical-Cancellous Threaded Screw 10.5 x 25
• 00197157030933: Cannulated Cortical-Cancellous Threaded Screw 9.5 x 110
• 00197157030926: Cannulated Cortical-Cancellous Threaded Screw 9.5 x 105
• 00197157030919: Cannulated Cortical-Cancellous Threaded Screw 9.5 x 100
• 00197157030902: Cannulated Cortical-Cancellous Threaded Screw 9.5 x 95
• 00197157030896: Cannulated Cortical-Cancellous Threaded Screw 9.5 x 90
• 00197157030889: Cannulated Cortical-Cancellous Threaded Screw 9.5 x 85
• 00197157030872: Cannulated Cortical-Cancellous Threaded Screw 9.5 x 80
• 00197157030865: Cannulated Cortical-Cancellous Threaded Screw 9.5 x 75
• 00197157030858: Cannulated Cortical-Cancellous Threaded Screw 9.5 x 70
• 00197157030841: Cannulated Cortical-Cancellous Threaded Screw 9.5 x 65
• 00197157030834: Cannulated Cortical-Cancellous Threaded Screw 9.5 x 60
• 00197157030827: Cannulated Cortical-Cancellous Threaded Screw 9.5 x 55
• 00197157030810: Cannulated Cortical-Cancellous Threaded Screw 9.5 x 50
• 00197157030803: Cannulated Cortical-Cancellous Threaded Screw 9.5 x 45
• 00197157030797: Cannulated Cortical-Cancellous Threaded Screw 9.5 x 40
• 00197157030780: Cannulated Cortical-Cancellous Threaded Screw 9.5 x 35
• 00197157030773: Cannulated Cortical-Cancellous Threaded Screw 9.5 x 30
• 00197157030766: Cannulated Cortical-Cancellous Threaded Screw 9.5 x 25
• 00197157030759: Cannulated Cortical-Cancellous Threaded Screw 8.5 x 110
• 00197157030742: Cannulated Cortical-Cancellous Threaded Screw 8.5 x 105
• 00197157030735: Cannulated Cortical-Cancellous Threaded Screw 8.5 x 100
• 00197157030728: Cannulated Cortical-Cancellous Threaded Screw 8.5 x 95
• 00197157030711: Cannulated Cortical-Cancellous Threaded Screw 8.5 x 90
• 00197157030704: Cannulated Cortical-Cancellous Threaded Screw 8.5 x 85
• 00197157030698: Cannulated Cortical-Cancellous Threaded Screw 8.5 x 80
• 00197157030681: Cannulated Cortical-Cancellous Threaded Screw 8.5 x 75
• 00197157030674: Cannulated Cortical-Cancellous Threaded Screw 8.5 x 70
• 00197157030667: Cannulated Cortical-Cancellous Threaded Screw 8.5 x 65
• 00197157030650: Cannulated Cortical-Cancellous Threaded Screw 8.5 x 60
• 00197157030643: Cannulated Cortical-Cancellous Threaded Screw 8.5 x 55
• 00197157030636: Cannulated Cortical-Cancellous Threaded Screw 8.5 x 50
• 00197157030629: Cannulated Cortical-Cancellous Threaded Screw 8.5 x 45
• 00197157030612: Cannulated Cortical-Cancellous Threaded Screw 8.5 x 40
• 00197157030605: Cannulated Cortical-Cancellous Threaded Screw 8.5 x 35
• 00197157030599: Cannulated Cortical-Cancellous Threaded Screw 8.5 x 30
• 00197157030582: Cannulated Cortical-Cancellous Threaded Screw 8.5 x 25
• 00197157030575: Cannulated Cortical-Cancellous Threaded Screw 7.5 x 110
• 00197157030568: Cannulated Cortical-Cancellous Threaded Screw 7.5 x 105
• 00197157030551: Cannulated Cortical-Cancellous Threaded Screw 7.5 x 100
• 00197157030544: Cannulated Cortical-Cancellous Threaded Screw 7.5 x 95
• 00197157030537: Cannulated Cortical-Cancellous Threaded Screw 7.5 x 90
• 00197157030520: Cannulated Cortical-Cancellous Threaded Screw 7.5 x 85
• 00197157030513: Cannulated Cortical-Cancellous Threaded Screw 7.5 x 80
• 00197157030506: Cannulated Cortical-Cancellous Threaded Screw 7.5 x 75
• 00197157030490: Cannulated Cortical-Cancellous Threaded Screw 7.5 x 70
• 00197157030483: Cannulated Cortical-Cancellous Threaded Screw 7.5 x 65