Superion Retractor 100-9126

GUDID 00884662000192

Superion Retractor

VERTIFLEX, INC.

Lumbar interspinous decompression instrument set, reusable Lumbar interspinous decompression instrument set, reusable Lumbar interspinous decompression instrument set, reusable Lumbar interspinous decompression instrument set, reusable Lumbar interspinous decompression instrument set, reusable Lumbar interspinous decompression instrument set, reusable Lumbar interspinous decompression instrument set, reusable Lumbar interspinous decompression instrument set, reusable Lumbar interspinous decompression instrument set, reusable Lumbar interspinous decompression instrument set, reusable Lumbar interspinous decompression instrument set, reusable Lumbar interspinous decompression instrument set, reusable Lumbar interspinous decompression instrument set, reusable Lumbar interspinous decompression instrument set, reusable Lumbar interspinous decompression instrument set, reusable Lumbar interspinous decompression instrument set, reusable
Primary Device ID00884662000192
NIH Device Record Key6b447a4d-3b06-41a2-a438-11369a91894f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSuperion Retractor
Version Model NumberN/A
Catalog Number100-9126
Company DUNS005235436
Company NameVERTIFLEX, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100884662000192 [Primary]

FDA Product Code

NQOProsthesis, Spinous Process Spacer/Plate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00884662000192]

Moist Heat or Steam Sterilization


[00884662000192]

Moist Heat or Steam Sterilization


[00884662000192]

Moist Heat or Steam Sterilization


[00884662000192]

Moist Heat or Steam Sterilization


[00884662000192]

Moist Heat or Steam Sterilization


[00884662000192]

Moist Heat or Steam Sterilization


[00884662000192]

Moist Heat or Steam Sterilization


[00884662000192]

Moist Heat or Steam Sterilization


[00884662000192]

Moist Heat or Steam Sterilization


[00884662000192]

Moist Heat or Steam Sterilization


[00884662000192]

Moist Heat or Steam Sterilization


[00884662000192]

Moist Heat or Steam Sterilization


[00884662000192]

Moist Heat or Steam Sterilization


[00884662000192]

Moist Heat or Steam Sterilization


[00884662000192]

Moist Heat or Steam Sterilization


[00884662000192]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-08-16

Devices Manufactured by VERTIFLEX, INC.

00884662000529 - Superion Indirect Decompression System2020-10-06 Superion Indirect Decompression System, 8mm
00884662000574 - Superion IDS Kit2019-07-25 Superion IDS Kit includes a Driver (102-9108), Inserter (102-9110), & Interspinous Gauge (102-9115)
00884662000611 - Vertiflex Instrument Platform2019-07-25 Vertiflex Instrument Platform includes a Dilator Assembly (140-9501), Cannula Assembly (140-9502), & Reamer (140-9503)
00088466000529 - Superion Indirect Decompression System2019-03-07 Superion Indirect Decompression System, 8mm
00884662000536 - Superion Indirect Decompression System2019-03-07 Superion Indirect Decompression System, 10mm
00884662000543 - Superion Indirect Decompression System2019-03-07 Superion Indirect Decompression System, 12mm
00884662000550 - Superion Indirect Decompression System2019-03-07 Superion Indirect Decompression System, 14mm
00884662000567 - Superion Indirect Decompression System2019-03-07 Superion Indirect Decompression System, 16mm

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.