Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030989819

FEI Number

3030989819

Entity Name

PB SWISS TOOLS AG

City/State/Country

Gruenen Bern, CH

Establishment Address

Eystrasse 30, Gruenen Bern 3455, 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 screw driver insert Operace screw recess trial Operace handle and extensions

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2024-05-03
HXB	Probe	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
3013043133	PB SWISS TOOLS AG	Wasen/Bern, CH

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

Similar Registrations

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3009959868	Ferry Machine Corporation	Little Ferry, NJ, US
8010916	Kammerer Medical Systems GmbH & Co. KG	Stockach Baden-Wurttemberg, DE
3007689689	ELOS MEDTECH PINOL A/S	Goerloese Hovedstaden, DK
1038671	EXACTECH, INC.	GAINESVILLE, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030989819. Last updated year: 2026. Please use registration number 3030989819 when referencing this establishment in official correspondence.