VERTEBRAL SPACER-TR 08804012

GUDID H981088040120

VERTEBRAL SPACER-TR 10MMX27MM 12MM HEIGHT

SYNTHES (U.S.A.) LP

Polymeric spinal interbody fusion cage

• Primary Device ID: H981088040120
• NIH Device Record Key: e5c7a1c9-9175-42b1-8cb7-7050acfc410b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VERTEBRAL SPACER-TR
• Version Model Number: 08.804.012
• Catalog Number: 08804012
• Company DUNS: 832637081
• Company Name: SYNTHES (U.S.A.) LP
• 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: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034754734 [Primary]
HIBCC	H981088040120 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011037

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

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

[H981088040120]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-09-14

On-Brand Devices [VERTEBRAL SPACER-TR]

• H9818898390: VERTEBRAL SPACER-TR 10MMX27MM 17MM HEIGHT
• H9818898380: VERTEBRAL SPACER-TR 10MMX27MM 15MM HEIGHT
• H9818898370: VERTEBRAL SPACER-TR 10MMX27MM 13MM HEIGHT
• H9818898360: VERTEBRAL SPACER-TR 10MMX27MM 11MM HEIGHT
• H9818898350: VERTEBRAL SPACER-TR 10MMX27MM 9MM HEIGHT
• H9818898340: VERTEBRAL SPACER-TR 10MMX27MM 7MM HEIGHT
• H981088041770: VERTEBRAL SPACER-TR 12MMX33MM 17MM HEIGHT
• H981088041750: VERTEBRAL SPACER-TR 12MMX33MM 15MM HEIGHT
• H981088041730: VERTEBRAL SPACER-TR 12MMX33MM 13MM HEIGHT
• H981088041720: VERTEBRAL SPACER-TR 12MMX33MM 12MM HEIGHT
• H981088041710: VERTEBRAL SPACER-TR 12MMX33MM 11MM HEIGHT
• H981088041700: VERTEBRAL SPACER-TR 12MMX33MM 10MM HEIGHT
• H981088041690: VERTEBRAL SPACER-TR 12MMX33MM 9MM HEIGHT
• H981088041680: VERTEBRAL SPACER-TR 12MMX33MM 8MM HEIGHT
• H981088041670: VERTEBRAL SPACER-TR 12MMX33MM 7MM HEIGHT
• H981088041470: VERTEBRAL SPACER-TR 12MMX30MM 17MM HEIGHT
• H981088041450: VERTEBRAL SPACER-TR 12MMX30MM 15MM HEIGHT
• H981088041430: VERTEBRAL SPACER-TR 12MMX30MM 13MM HEIGHT
• H981088041420: VERTEBRAL SPACER-TR 12MMX30MM 12MM HEIGHT
• H981088041410: VERTEBRAL SPACER-TR 12MMX30MM 11MM HEIGHT
• H981088041400: VERTEBRAL SPACER-TR 12MMX30MM 10MM HEIGHT
• H981088041390: VERTEBRAL SPACER-TR 12MMX30MM 9MM HEIGHT
• H981088041380: VERTEBRAL SPACER-TR 12MMX30MM 8MM HEIGHT
• H981088041370: VERTEBRAL SPACER-TR 12MMX30MM 7MM HEIGHT
• H981088041170: VERTEBRAL SPACER-TR 12MMX27MM 17MM HEIGHT
• H981088041150: VERTEBRAL SPACER-TR 12MMX27MM 15MM HEIGHT
• H981088041130: VERTEBRAL SPACER-TR 12MMX27MM 13MM HEIGHT
• H981088041120: VERTEBRAL SPACER-TR 12MMX27MM 12MM HEIGHT
• H981088041110: VERTEBRAL SPACER-TR 12MMX27MM 11MM HEIGHT
• H981088041100: VERTEBRAL SPACER-TR 12MMX27MM 10MM HEIGHT
• H981088041090: VERTEBRAL SPACER-TR 12MMX27MM 9MM HEIGHT
• H981088041080: VERTEBRAL SPACER-TR 12MMX27MM 8MM HEIGHT
• H981088041070: VERTEBRAL SPACER-TR 12MMX27MM 7MM HEIGHT
• H981088040770: VERTEBRAL SPACER-TR 10MMX33MM 17MM HEIGHT
• H981088040750: VERTEBRAL SPACER-TR 10MMX33MM 15MM HEIGHT
• H981088040730: VERTEBRAL SPACER-TR 10MMX33MM 13MM HEIGHT
• H981088040720: VERTEBRAL SPACER-TR 10MMX33MM 12MM HEIGHT
• H981088040710: VERTEBRAL SPACER-TR 10MMX33MM 11MM HEIGHT
• H981088040700: VERTEBRAL SPACER-TR 10MMX33MM 10MM HEIGHT
• H981088040690: VERTEBRAL SPACER-TR 10MMX33MM 9MM HEIGHT
• H981088040680: VERTEBRAL SPACER-TR 10MMX33MM 8MM HEIGHT
• H981088040670: VERTEBRAL SPACER-TR 10MMX33MM 7MM HEIGHT
• H981088040470: VERTEBRAL SPACER-TR 10MMX30MM 17MM HEIGHT
• H981088040450: VERTEBRAL SPACER-TR 10MMX30MM 15MM HEIGHT
• H981088040430: VERTEBRAL SPACER-TR 10MMX30MM 13MM HEIGHT
• H981088040420: VERTEBRAL SPACER-TR 10MMX30MM 12MM HEIGHT
• H981088040410: VERTEBRAL SPACER-TR 10MMX30MM 11MM HEIGHT
• H981088040400: VERTEBRAL SPACER-TR 10MMX30MM 10MM HEIGHT
• H981088040390: VERTEBRAL SPACER-TR 10MMX30MM 9MM HEIGHT
• H981088040380: VERTEBRAL SPACER-TR 10MMX30MM 8MM HEIGHT