COALESCE

GUDID B14220000128120

10x28x12MM COALESCE-Curved, Lordotic

VERTERA, INC.

Polymeric spinal fusion cage, sterile

• Primary Device ID: B14220000128120
• NIH Device Record Key: 28079cec-e73d-414a-983b-c077d7878048
• Commercial Distribution Discontinuation: 2018-11-09
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: COALESCE
• Version Model Number: 2000-01-2812
• Company DUNS: 078812764
• Company Name: VERTERA, 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B14220000128120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143685

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-10
• Device Publish Date: 2018-11-09

On-Brand Devices [COALESCE]

• B14220000132160: 11x32x16MM COALESCE-Curved, Lordotic
• B14220000132140: 11x32x14MM COALESCE-Curved, Lordotic
• B14220000132120: 11x32x12MM COALESCE-Curved, Lordotic
• B14220000132110: 11x32x11MM COALESCE-Curved, Lordotic
• B14220000132100: 11x32x10MM COALESCE-Curved, Lordotic
• B14220000132090: 11x32x9MM COALESCE-Curved, Lordotic
• B14220000132080: 11x32x8MM COALESCE-Curved, Lordotic
• B14220000128140: 10x28x14MM COALESCE-Curved, Lordotic
• B14220000128120: 10x28x12MM COALESCE-Curved, Lordotic
• B14220000128110: 10x28x11MM COALESCE-Curved, Lordotic
• B14220000128100: 10x28x10MM COALESCE-Curved, Lordotic
• B14220000128090: 10x28x9MM COALESCE-Curved, Lordotic
• B14220000128080: 10x28x8MM COALESCE-Curved, Lordotic
• B1422000001014080: 10x28x14MM COALESCE-Straight, Lordotic
• B1422000001012080: 10x28x12MM COALESCE-Straight, Lordotic
• B1422000001011080: 10x28x11MM COALESCE-Straight, Lordotic
• B1422000001010080: 10x28x10MM COALESCE-Straight, Lordotic
• B1422000001009080: 10x28x9MM COALESCE-Straight, Lordotic
• B1422000001008080: 10x28x8MM COALESCE-Straight, Lordotic
• B1422000000914080: 9x23x14MM COALESCE-Straight, Lordotic
• B1422000000914000: 9x23x14MM COALESCE-Straight, Parallel
• B1422000000912080: 9x23x12MM COALESCE-Straight, Lordotic
• B1422000000912000: 9x23x12MM COALESCE-Straight, Parallel
• B1422000000911080: 9x23x11MM COALESCE-Straight, Lordotic
• B1422000000911000: 9x23x11MM COALESCE-Straight, Parallel
• B1422000000910080: 9x23x10MM COALESCE-Straight, Lordotic
• B1422000000910000: 9x23x10MM COALESCE-Straight, Parallel
• B1422000000909080: 9x23x9MM COALESCE-Straight, Lordotic
• B1422000000909000: 9x23x9MM COALESCE-Straight, Parallel
• B1422000000908080: 9x23x8MM COALESCE-Straight, Lordotic
• B1422000000908000: 9x23x8MM COALESCE-Straight, Parallel