UniVise 48590040

GUDID 07613327065657

SPINOUS PROCESS FIXATION PLATE

Stryker Corporation

Lumbar interspinous decompression spacer, sterile

• 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