Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021389310

FEI Number

3021389310

Entity Name

SPIRECUT SA

City/State/Country

Muttenz Basel-Landschaft, CH

Establishment Address

Hofackerstrasse 40B, Muttenz Basel-Landschaft 4132, CH

Establishment Type(s)

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

Owner / Operator

Spirecut AG (Owner Number: 10083885)

Owner / Operator Contact Address

Hofackerstrasse 40B, Muttenz, CH-BL 4132, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sono-Bath®

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2025-12-17
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2022-01-04

Official Correspondent

Damien Vallelian

US Agent Details

Terry Pracht Email: service@psm-na.us Phone: (614) 5544446

Related Public Records

Same Entity

Spirecut AG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021389310. Last updated year: 2026. Please use registration number 3021389310 when referencing this establishment in official correspondence.