Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007766601

FEI Number

3007766601

Entity Name

STERIPACK MEDICAL POLAND SP. Z O.O.

City/State/Country

Jelcz-Laskowice Dolnoslaskie, PL

Establishment Address

Leg, ul. Japonska 1, Jelcz-Laskowice Dolnoslaskie 55-220, PL

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SteriPack Medical Poland Sp. z o.o. (Owner Number: 10029329)

Owner / Operator Contact Address

Leg, ul. Japonska 1, Jelcz-Laskowice, PL-NOTA 55-220, PL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ARIA NM PROBE/GUIDE WIRE ARIA DILATOR 6.5MM ARIA DILATOR 22.5MM DePuy Synthes Locking Screws for Medullary Nails, 4 and 5 mm DePuy Synthes Tibial Nail Advanced System GAMMA3 - INSTRUMENTS Orthopedic Manual Surgical Instrument T2 - INSTRUMENTS Rapid-I Kit PROFORE Pill Sense System Sterile Polyester Spun Swab ARIA DILATOR 14.5MM NM Transducer Cover MER Cable, Micro Electrode Recording Cable SURGIFLO® Hemostatic Matrix Kit neoClose AnchorGuide

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GXZ	Electrode, Needle	Neurology	Class 2	882.1350	2013-01-22
MGB	Device, Hemostasis, Vascular	Unknown	Class 3	N/A	2017-08-02
JDS	Nail, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-07-20
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-07-20
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2013-01-22
MQK	Labware, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6160	2021-02-01
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2009-05-01
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2023-09-01
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2023-09-01
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2012-11-23
QUD	Blood Detection Capsule	Gastroenterology, Urology	Class 2	876.1390	2023-06-14
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2021-02-01
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2013-01-22
HEM	Imager, Ultrasonic Obstetric-Gynecologic	Obstetrics/Gynecology	Class 2	884.2225	2017-04-19
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2015-03-03
LMF	Agent, Absorbable Hemostatic, Collagen Based	General, Plastic Surgery	Class 3	878.4490	2015-04-08
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2014-01-30

Official Correspondent

Sylwia Guszpit

US Agent Details

Marinela Cebic Business: SteriPack USA (Limited) LLC Email: m.cebic@steripackgroup.com Phone: (863) 6482333

Related Public Records

Same Entity

SteriPack Medical Poland 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
K062348	Medtronic Neurosurgery	TIMESH SELF DRILLING SCREW	2006-09-08
K063244	Arc Surgical, LLC	ARC SURGICAL BONE REDUCTION SCREW	2006-12-27
K972722	Orthopedic Designs, Inc.	ULTIMATE COMPRESSION SCREW SYSTEM	1998-01-23
K192974	Tyber Medical, LLC	Tyber Medical Trauma Screw	2020-01-08
K082949	OrthoPediatrics Corp.	ORTHOPEDIATRICS BONE SCREWS	2008-11-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-06	N/A	2	EBI Trochanteric 11mm Long Nail.
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.

Similar Registrations

Registration Number	Establishment Name	Location
1048735	STERILIZATION SERVICES OF GEORGIA, INC.	ATLANTA, GA, US
9610691	Ambu A/S	Ballerup Hovedstaden, DK
2246552	Isomedix Operations Inc.	S Plainfield, NJ, US
3003851073	Xian Friendship Medical Electronics Co., Ltd.	Xi'an Shaanxi, CN
3006697681	PINE MOON ELECTRONICS CO., LTD.	SHENZHEN CITY Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007766601. Last updated year: 2026. Please use registration number 3007766601 when referencing this establishment in official correspondence.