Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002736229

FEI Number

3002736229

Entity Name

SPIERINGS ORTHOPAEDICS B.V.

City/State/Country

NIJMEGEN Gelderland, NL

Establishment Address

MADOERASTRAAT 24, NIJMEGEN Gelderland 6524 LH, NL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SPIERINGS ORTHOPAEDICS B.V. (Owner Number: 9049841)

Owner / Operator Contact Address

MADOERASTRAAT 24, --, NIJMEGEN, NL-NOTA 6524 LH, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Noviomagus Bone Mill Noviomagus Femoral Head Reamer Set

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYS	Bone Mill	Orthopedic	Class 1	888.4540	2002-02-21
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2024-03-14
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2007-04-05

Official Correspondent

P.T.J. SPIERINGS

US Agent Details

William R. Krause Business: Flex Technology Inc Email: flextechnology@yahoo.com Phone: (434) 9794134

Related Public Records

Same Entity

SPIERINGS ORTHOPAEDICS B.V.

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-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

Registration Number	Establishment Name	Location
3005809810	Jarit GmbH	Rietheim-Weilheim Baden-Wurttemberg, DE
1625507	MEDTRONIC POWERED SURGICAL SOLUTIONS	FORT WORTH, TX, US
2246990	J & J INSTRUMENTS, LLC	Stratford, CT, US
1061927	INTERNATIONAL STERILIZATION LABORATORY, LLC	GROVELAND, FL, US
1834331	PARAGON MEDICAL, INC.	PIERCETON, IN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002736229. Last updated year: 2026. Please use registration number 3002736229 when referencing this establishment in official correspondence.