Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021562582

FEI Number

3021562582

Entity Name

Spinal Stabilization Technologies, LTD

City/State/Country

Kilkenny, IE

Establishment Address

Unit 4, Kilkenny Enterprise Centre, IDA Ireland Purcellsinch Business Park, Kilkenny R95 PD87, IE

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Spinal Stabilization Technologies, LTD (Owner Number: 10095327)

Owner / Operator Contact Address

Unit 4 Kilkenny Enterprise Center, IDA Ireland Purcellsinch Business Park, Kilkenny, IE-KK R95 PD87, IE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Envision Balloon Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GBA	Catheter, Balloon Type	General, Plastic Surgery	Class 1	878.4200	2026-02-26

Official Correspondent

Molly Bond

US Agent Details

Mark Novotny Business: Spinal Stabilization Technologies, LLC Email: mnovotny@sstspine.com Phone: (763) 2340836

Related Public Records

Same Entity

Spinal Stabilization Technologies, LTD

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 3021562582. Last updated year: 2026. Please use registration number 3021562582 when referencing this establishment in official correspondence.