Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003973936

FEI Number

3003973936

Entity Name

BESTER MEDICAL SYSTEM SP. Z O. O.

City/State/Country

Nowa Deba Podkarpackie, PL

Establishment Address

ul. COP-u 11, Nowa Deba Podkarpackie 39-460, PL

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Bester Medical System Sp. z o. o. (Owner Number: 10048381)

Owner / Operator Contact Address

ul. COP-u 11, Nowa Deba, PL-18 39-460, PL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Arthrex Arthrex Arthrex Arthrex

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2018-11-14
HWT	Template	Orthopedic	Class 1	888.4800	2019-05-28
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2015-01-07
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2015-08-18
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2018-02-06
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2015-08-18
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2015-08-20
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2015-08-18
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2018-07-31
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2018-07-05

Official Correspondent

Robert Jankowski-Koc

US Agent Details

Richard Hayes Business: LAB MEDICAL MANUFACTURING, INC. Email: richardhayes@labmedical.com Phone: (978) 5285679

Related Public Records

Same Entity

Bester Medical System Sp. z o. o.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K953012	Boston Surgical Products, Inc.	DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS	1995-07-12
K812396	Northwest Surgical Concepts, Inc.	ARTHRO-PREP REST	1981-11-20

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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3010591625	GOMINA AG	Niederwald Valais, CH
3005575604	SURETEK MEDICAL	GREENVILLE, SC, US
8043971	T.A.G. MEDICAL PRODUCTS CORPORATION LTD	GAATON Northern, IL
3027344440	TRITEX MEDICAL MANUFACTURING LLC	Mount Morris, MI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003973936. Last updated year: 2026. Please use registration number 3003973936 when referencing this establishment in official correspondence.