Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013223655

FEI Number

3013223655

Entity Name

Incipio Devices SA

City/State/Country

St Blaise Neuchatel, CH

Establishment Address

Av. des Paquiers 16, St Blaise Neuchatel 2072, CH

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Incipio Devices SA (Owner Number: 10089271)

Owner / Operator Contact Address

Avenue des Paquiers 16, St. Blaise, CH-NE 2072, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cup Instrument System - Instrument Tray Offset Reamer Handle - Instrument Tray Angled Reamer Handle - Instrument Tray Offset Cup Impactor Orientable Alignment Guide Acetabular Reamer

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	2023-11-22
HWA	Impactor	Orthopedic	Class 1	888.4540	2023-11-22
HWT	Template	Orthopedic	Class 1	888.4800	2023-11-22
HTO	Reamer	Orthopedic	Class 1	888.4540	2023-11-22

Official Correspondent

Chris Taylor

US Agent Details

Barry Sands Business: Regulatory/Quality Management Information Source, Inc. Email: fdaadminsupport@rqmis.com Phone: (978) 8345701

Related Public Records

Same Entity

Incipio Devices SA

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.
Z-0010-2008	N/A	1	EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.
Z-0021-2015	Biomet, Inc.	1	Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013223655. Last updated year: 2026. Please use registration number 3013223655 when referencing this establishment in official correspondence.