SPIWay, LLC

FDA Device Registration & Listing · Carlsbad, CA, US · Registration 3010880816

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3010880816
FEI Number
3010880816
Entity Name
SPIWay, LLC
City/State/Country
Carlsbad, CA, US
Establishment Address
3600 Corte Castillo, Carlsbad, CA 92009, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
SPIWay, LLC (Owner Number: 10046778)
Owner / Operator Contact Address
3600 Corte Castillo, Carlsbad, CA 92009, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K213153
PMA Number
N/A

All Registered Proprietary Names

SPIWay SPIWay

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LYA Splint, Intranasal Septal Ear, Nose, Throat Class 1 874.4780 2016-11-21
LYA Splint, Intranasal Septal Ear, Nose, Throat Class 1 874.4780 2021-12-27

Official Correspondent

Elaine Tronic

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SPIWay, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010880816. Last updated year: 2026. Please use registration number 3010880816 when referencing this establishment in official correspondence.
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