Zavation Dilator

GUDID 00197157048891

DILATOR 2 PEEK

Zavation LLC

Internal spinal fixation procedure kit, reusable

• Primary Device ID: 00197157048891
• NIH Device Record Key: 37c9f762-dc8d-483f-8fb1-728ad27e6316
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zavation Dilator
• Version Model Number: ZAV-1369
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00197157048891 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222614

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00197157048891]

Moist Heat or Steam Sterilization

[00197157048891]

Moist Heat or Steam Sterilization

[00197157048891]

Moist Heat or Steam Sterilization

[00197157048891]

Moist Heat or Steam Sterilization

[00197157048891]

Moist Heat or Steam Sterilization

[00197157048891]

Moist Heat or Steam Sterilization

[00197157048891]

Moist Heat or Steam Sterilization

[00197157048891]

Moist Heat or Steam Sterilization

[00197157048891]

Moist Heat or Steam Sterilization

[00197157048891]

Moist Heat or Steam Sterilization

[00197157048891]

Moist Heat or Steam Sterilization

[00197157048891]

Moist Heat or Steam Sterilization

[00197157048891]

Moist Heat or Steam Sterilization

[00197157048891]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-24
• Device Publish Date: 2024-10-16

Devices Manufactured by Zavation LLC

• 00197157029289 - Zavation CUSTOM DRILL: 2024-11-14 CUSTOM DRILL
• 00197157049546 - Zavation PEDICAL HEAD ROTATOR: 2024-11-14 PEDICAL HEAD ROTATOR
• 00842166121546 - Zavation ZVplasty System Assembly: 2024-11-11 ZVplasty System Assembly
• 00197157049133 - Zavation SLAP HAMMER: 2024-11-07 SLAP HAMMER
• 00197157049140 - Zavation MALLET: 2024-11-07 MALLET
• 00197157010287 - Zavation Torque Shaft: 2024-11-04 Connector System Torque Shaft
• 00197157045722 - Zavation Deformity Polyaxial Screw: 2024-11-04 Fenestrated Standard Threaded Screw 6.5 x 85
• 00197157045739 - Zavation Deformity Polyaxial Screw: 2024-11-04 Fenestrated Standard Threaded Screw 6.5 x 90