UniVise 48590040

GUDID 07613327065657

SPINOUS PROCESS FIXATION PLATE

Stryker Corporation

Lumbar interspinous decompression spacer, sterile Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer

• Primary Device ID: 07613327065657
• NIH Device Record Key: bcd15481-9037-41d3-9abd-3445fbf75ea8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UniVise
• Version Model Number: 48590040
• Catalog Number: 48590040
• Company DUNS: 149183167
• Company Name: Stryker Corporation
• 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: true
• 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 Dimensions

• Length: 40 Millimeter
• Length: 40 Millimeter
• Length: 40 Millimeter
• Length: 40 Millimeter
• Length: 40 Millimeter
• Length: 40 Millimeter
• Length: 40 Millimeter
• Length: 40 Millimeter
• Length: 40 Millimeter
• Length: 40 Millimeter
• Length: 40 Millimeter
• Length: 40 Millimeter
• Length: 40 Millimeter
• Length: 40 Millimeter
• Length: 40 Millimeter
• Length: 40 Millimeter
• Length: 40 Millimeter
• Length: 40 Millimeter
• Length: 40 Millimeter
• Length: 40 Millimeter
• Length: 40 Millimeter
• Length: 40 Millimeter
• Length: 40 Millimeter
• Length: 40 Millimeter
• Length: 40 Millimeter
• Length: 40 Millimeter
• Length: 40 Millimeter
• Length: 40 Millimeter
• Length: 40 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327065657 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122509

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

On-Brand Devices [UniVise]

• 07613327281163: Specialty Spinous Process Distractor
• 07613327065657: SPINOUS PROCESS FIXATION PLATE
• 07613327065640: SPINOUS PROCESS FIXATION PLATE