Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013043133

FEI Number

3013043133

Entity Name

PB SWISS TOOLS AG

City/State/Country

Wasen/Bern, CH

Establishment Address

Bahnhofstrasse 24, Wasen/Bern 3457, CH

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PB Swiss Tools AG (Owner Number: 10090481)

Owner / Operator Contact Address

Bahnhofstrasse 24, Wasen/Bern, CH-BE 3457, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Operace extraction drill bit Operace extraction screw Operace extraction reamer Operace handle and extensions

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GFF	Bur, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4820	2024-05-03
HWB	Extractor	Orthopedic	Class 1	888.4540	2024-05-03
HTO	Reamer	Orthopedic	Class 1	888.4540	2024-05-03
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2024-05-03

Official Correspondent

Rudolf Zihlmann

US Agent Details

Lance D. Johnson Business: LDJCG LLC. Email: Lance@LDJCG.com Phone: (512) 7757610

Related Public Records

Same Entity

PB Swiss Tools AG

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3030989819	PB SWISS TOOLS AG	Gruenen Bern, CH

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013043133. Last updated year: 2026. Please use registration number 3013043133 when referencing this establishment in official correspondence.