FDA.reportPublic FDA data

SPIWay, LLC

Matched from indexed company URL: SPIWAY LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30108808163010880816SPIWay, LLC1N2026-01-013600 Corte Castillo Carlsbad CA US 92009

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00860003136409SPIWay - SPIWay Endonasal Access Guide Size Large1-844-565-1226orders@spiway.com
00860003136416SPIWay - SPIWay Endonasal Access Guide Size Medium1-844-565-1226orders@spiway.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1713091408650599K213153SPIWay Endonasal Access GuideLYA2021-10-27
1713091017705451K180141SPIWay Endonasal Access GuideLYA2018-02-16
1713091527607625K153686SPIWay Endonasal Access GuideLYA2016-01-28

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LYA32021-10-27

PMN#

GUDID#