Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031800723

FEI Number

3031800723

Entity Name

Stryker Poland Manufacturing Sp. z o.o.

City/State/Country

Skawina Malopolskie, PL

Establishment Address

Pulkownika Andrzeja Halacinskiego 1, Skawina Malopolskie 32-050, PL

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

STRYKER CORP. (Owner Number: 1811755)

Owner / Operator Contact Address

4100 East Milham Ave., Kalamazoo, MI 49001, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ORTHOLOC 3Di Foot Reconstruction System ORTHOLOC 3Di Hallux System Asnis® III Cannulated Screw System And Asnis® PRO Cannulated Screw System ORTHOLOC, ORTHOLOC 3Di Hoffmann 3 Hoffmann 3 Pangea Utility Plating System Pangea Platform Hoffmann 3 Modular External Fixation System Variax Pangea Platform Pangea Femur Plating System Pangea Tibia Plating System Pangea Humerus Plating System PRO Plating System Stryker Trauma Pelvic Set (Matta)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-23
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-01-31
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2022-01-31
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-23
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-23
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2012-01-31
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2013-02-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-09-20
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-09-20
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2012-07-30
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2010-12-15
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-10-14
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-10-14
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-04-14
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-04-14

Official Correspondent

No official correspondent registered.

US Agent Details

Shamaila Rafiq Business: Stryker Email: Shamaila.Rafiq@stryker.com Phone: (201) 3769049

Related Public Records

Same Entity

STRYKER CORP.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003897776	BIOMIMETIC THERAPEUTICS,LLC	FRANKLIN, TN, US
3040801290	Inari Medical, Costa Rica S.A.	Grecia Alajuela, CR
2031049	TMJ Solutions, LLC	San Buenaventura, CA, US
3016573902	Ortho-Space Ltd.	Caesarea Haifa, IL
3010411911	POM Medical, LLC	Moorpark, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K042598	Zimmer, Inc.	PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES	2004-10-29
K190842	Jiangsu Trauhui Medical Instrument Co., Ltd.	Comus Locking Plate systems	2020-02-03
K130510	Arthrex, Inc.	ARTHREX COMPRESSION PLATES	2013-09-25
K202803	Newclip Technics	Activmotion S DTO	2021-12-16
K062348	Medtronic Neurosurgery	TIMESH SELF DRILLING SCREW	2006-09-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0034-2022	Flower Orthopedics Corporation	2	Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Z-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016	Ortho Solutions Inc 330 Franklin Tnpk	2	Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031800723. Last updated year: 2026. Please use registration number 3031800723 when referencing this establishment in official correspondence.