Accent® Cervical Spacer System 15-4011

GUDID 10840642103175

Spacer 12mm X 14mm X 11mm 0deg

Spine Wave, Inc.

Polymeric spinal interbody fusion cage

• Primary Device ID: 10840642103175
• NIH Device Record Key: 6a057384-44a9-42cd-9011-1614e3798a38
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accent® Cervical Spacer System
• Version Model Number: 15-4011
• Catalog Number: 15-4011
• Company DUNS: 067789763
• Company Name: Spine Wave, Inc.
• 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: 203-944-9494
• Email: GUDID@spinewave.com

Device Dimensions

• Length: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840642103175 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091531

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

[10840642103175]

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: 2015-10-24

On-Brand Devices [Accent® Cervical Spacer System]

• 10840642103496: Spacer 14mm X 16mm X 12mm 6deg
• 10840642103489: Spacer 14mm X 16mm X 11mm 6deg
• 10840642103472: Spacer 14mm X 16mm X 10mm 6deg
• 10840642103465: Spacer 14mm X 16mm X 9mm 6deg
• 10840642103458: Spacer 14mm X 16mm X 8mm 6deg
• 10840642103441: Spacer 14mm X 16mm X 7mm 6deg
• 10840642103434: Spacer 14mm X 16mm X 6mm 6deg
• 10840642103427: Spacer 14mm X 16mm X 5mm 6deg
• 10840642103410: Spacer 14mm X 16mm X 12mm 0deg
• 10840642103403: Spacer 14mm X 16mm X 11mm 0deg
• 10840642103397: Spacer 14mm X 16mm X 10mm 0deg
• 10840642103380: Spacer 14mm X 16mm X 9mm 0deg
• 10840642103373: Spacer 14mm X 16mm X 8mm 0deg
• 10840642103366: Spacer 14mm X 16mm X 7mm 0deg
• 10840642103359: Spacer 14mm X 16mm X 6mm 0deg
• 10840642103342: Spacer 14mm X 16mm X 5mm 0deg
• 10840642103335: Spacer 12mm X 14mm X 12mm 6deg
• 10840642103328: Spacer 12mm X 14mm X 11mm 6deg
• 10840642103311: Spacer 12mm X 14mm X 10mm 6deg
• 10840642103304: Spacer 12mm X 14mm X 9mm 6deg
• 10840642103298: Spacer 12mm X 14mm X 8mm 6deg
• 10840642103281: Spacer 12mm X 14mm X 7mm 6deg
• 10840642103274: Spacer 12mm X 14mm X 6mm 6deg
• 10840642103267: Spacer 12mm X 14mm X 5mm 6deg
• 10840642103182: Spacer 12mm X 14mm X 12mm 0deg
• 10840642103175: Spacer 12mm X 14mm X 11mm 0deg
• 10840642103168: Spacer 12mm X 14mm X 10mm 0deg
• 10840642103151: Spacer 12mm X 14mm X 9mm 0deg
• 10840642103144: Spacer 12mm X 14mm X 8mm 0deg
• 10840642103137: Spacer 12mm X 14mm X 7mm 0deg
• 10840642103120: Spacer 12mm X 14mm X 6mm 0deg
• 10840642103113: Spacer 12mm X 14mm X 5mm 0deg