Spiway L L C

FDA Filings

This page includes the latest FDA filings for Spiway L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3010880816
• FEI Number: 3010880816
• Name: SPIWay, LLC
• Owner & Operator: SPIWay, LLC
• Contact Address: 3600 Corte Castillo ; Carlsbad CA 92009 US
• Official Correspondent:
  • Mary Lou Mooney
  • x-949-9222741-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 3600 Corte Castillo ; Carlsbad, CA 92009 US
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
PMN K213153 SPIWay, LLC	SPIWay Endonasal Access Guide	2021-10-27
GUDID 00860003136416 SPIWAY LLC	SPIWay SP005	2020-08-12
GUDID 00860003136409 SPIWAY LLC	SPIWay SP004	2020-08-12
PMN K180141 | LYA SPIWay, LLC	SPIWay Endonasal Access Guide	2018-12-20
PMN K180141 SPIWay, LLC	SPIWay Endonasal Access Guide	2018-02-16
PMN K153686 | LYA SPIWay, LLC	SPIWay	2016-11-21
PMN K153686 SPIWAY LLC	SPIWay Endonasal Access Guide	2016-01-28
PMN K132721 SPIWAY LLC	SPIWAY ENDONASAL ACCESS GUIDE	2014-01-29