Superion Indirect Decompression System 101-9808

GUDID 00884662000529

Superion Indirect Decompression System, 8mm

VERTIFLEX, INC.

Lumbar interspinous decompression spacer, sterile

• Primary Device ID: 00884662000529
• NIH Device Record Key: 7bc29e20-8019-4380-b665-2d8ddfaeca19
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Superion Indirect Decompression System
• Version Model Number: 8mm
• Catalog Number: 101-9808
• Company DUNS: 005235436
• Company Name: VERTIFLEX, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• 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

Device Dimensions

• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
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• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
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• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
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• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter
• Width: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884662000529 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P140004

FDA Product Code

• NQO: Prosthesis, Spinous Process Spacer/Plate

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: 2020-10-06
• Device Publish Date: 2020-09-28

On-Brand Devices [Superion Indirect Decompression System]

• 00884662000567: Superion Indirect Decompression System, 16mm
• 00884662000550: Superion Indirect Decompression System, 14mm
• 00884662000543: Superion Indirect Decompression System, 12mm
• 00884662000536: Superion Indirect Decompression System, 10mm
• 00088466000529: Superion Indirect Decompression System, 8mm
• 00884662000529: Superion Indirect Decompression System, 8mm