VERTEBRAL SPACER-AR 889906

GUDID H9818899060

VERTEBRAL SPACER-AR LATERAL 19MM HEIGHT

SYNTHES (U.S.A.) LP

Polymeric spinal interbody fusion cage

• Primary Device ID: H9818899060
• NIH Device Record Key: 108b964b-7450-41bb-9188-c40f4d787043
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VERTEBRAL SPACER-AR
• Version Model Number: 889.906
• Catalog Number: 889906
• 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	10705034800448 [Primary]
HIBCC	H9818899060 [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

[H9818899060]

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-AR]

• H9818899770: VERTEBRAL SPACER-AR ANTEROLATERAL 21MM HEIGHT
• H9818899760: VERTEBRAL SPACER-AR ANTEROLATERAL 19MM HEIGHT
• H9818899750: VERTEBRAL SPACER-AR ANTEROLATERAL 17MM HEIGHT
• H9818899740: VERTEBRAL SPACER-AR ANTEROLATERAL 15MM HEIGHT
• H9818899730: VERTEBRAL SPACER-AR ANTEROLATERAL 13MM HEIGHT
• H9818899720: VERTEBRAL SPACER-AR ANTEROLATERAL 11MM HEIGHT
• H9818899710: VERTEBRAL SPACER-AR ANTEROLATERAL 9MM HEIGHT
• H9818899670: VERTEBRAL SPACER-AR ANTERIOR 21MM HEIGHT
• H9818899660: VERTEBRAL SPACER-AR ANTERIOR 19MM HEIGHT
• H9818899650: VERTEBRAL SPACER-AR ANTERIOR 17MM HEIGHT
• H9818899640: VERTEBRAL SPACER-AR ANTERIOR 15MM HEIGHT
• H9818899630: VERTEBRAL SPACER-AR ANTERIOR 13MM HEIGHT
• H9818899620: VERTEBRAL SPACER-AR ANTERIOR 11MM HEIGHT
• H9818899610: VERTEBRAL SPACER-AR ANTERIOR 9MM HEIGHT
• H9818899070: VERTEBRAL SPACER-AR LATERAL 21MM HEIGHT
• H9818899060: VERTEBRAL SPACER-AR LATERAL 19MM HEIGHT
• H9818899050: VERTEBRAL SPACER-AR LATERAL 17MM HEIGHT
• H9818899040: VERTEBRAL SPACER-AR LATERAL 15MM HEIGHT
• H9818899030: VERTEBRAL SPACER-AR LATERAL 13MM HEIGHT
• H9818899020: VERTEBRAL SPACER-AR LATERAL 11MM HEIGHT
• H9818899010: VERTEBRAL SPACER-AR LATERAL 9MM HEIGHT
• H9813050110: VERTEBRAL SPACER-AR LATERAL MODULE CASE
• H9813049220: VERTEBRAL SPACER-AR MODULE CASE