Vertiflex Instrument Platform 140-9800

GUDID 00884662000611

Vertiflex Instrument Platform includes a Dilator Assembly (140-9501), Cannula Assembly (140-9502), & Reamer (140-9503)

VERTIFLEX, INC.

Lumbar interspinous decompression instrument set, single-use

• Primary Device ID: 00884662000611
• NIH Device Record Key: 5737ccae-5598-4727-94bb-667a42d755b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vertiflex Instrument Platform
• Version Model Number: 140-9800
• Catalog Number: 140-9800
• Company DUNS: 005235436
• Company Name: VERTIFLEX, 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: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00884662000611 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P140004
• 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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-07-25
• Device Publish Date: 2018-04-05

Devices Manufactured by VERTIFLEX, INC.

• 00884662000529 - Superion Indirect Decompression System: 2020-10-06 Superion Indirect Decompression System, 8mm
• 00884662000574 - Superion IDS Kit: 2019-07-25 Superion IDS Kit includes a Driver (102-9108), Inserter (102-9110), & Interspinous Gauge (102-9115)
• 00884662000611 - Vertiflex Instrument Platform: 2019-07-25Vertiflex Instrument Platform includes a Dilator Assembly (140-9501), Cannula Assembly (140-9502), & Reamer (140-9503)
• 00884662000611 - Vertiflex Instrument Platform: 2019-07-25 Vertiflex Instrument Platform includes a Dilator Assembly (140-9501), Cannula Assembly (140-9502), & Reamer (140-9503)
• 00088466000529 - Superion Indirect Decompression System: 2019-03-07 Superion Indirect Decompression System, 8mm
• 00884662000536 - Superion Indirect Decompression System: 2019-03-07 Superion Indirect Decompression System, 10mm
• 00884662000543 - Superion Indirect Decompression System: 2019-03-07 Superion Indirect Decompression System, 12mm
• 00884662000550 - Superion Indirect Decompression System: 2019-03-07 Superion Indirect Decompression System, 14mm
• 00884662000567 - Superion Indirect Decompression System: 2019-03-07 Superion Indirect Decompression System, 16mm