Superion Indirect Decompression System 101-9816

GUDID 00884662000567

Superion Indirect Decompression System, 16mm

VERTIFLEX, INC.

Lumbar interspinous decompression spacer, sterile

Primary Device ID	00884662000567
NIH Device Record Key	a57ff9cd-3547-44c3-bb5e-f6778fe8151b
Commercial Distribution Status	In Commercial Distribution
Brand Name	Superion Indirect Decompression System
Version Model Number	16mm
Catalog Number	101-9816
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	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter
Width	16 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884662000567 [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	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2019-03-07
Device Publish Date	2019-02-04

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

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