FDA Registration
Active
🇵🇱 Poland
Stryker Poland Manufacturing Sp. z o.o.
Reg #: 3031800723
·
FEI: 3031800723
·
Expires 2026
Products
4
Proprietary Names
19
Establishment Types
1
Classifications
4
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Registration Details
- Registration Name
- Stryker Poland Manufacturing Sp. z o.o.
- Registration Number
- 3031800723
- FEI Number
- 3031800723
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Pulkownika Andrzeja Halacinskiego 1
- City
- Skawina Malopolskie
- Country
- PL
Owner / Operator
- Firm Name
- STRYKER CORP.
- Operator Number
- 1811755
- Address
- 4100 East Milham Ave.
- City
- Kalamazoo
- State
- MI
- Postal Code
- 49001
- Country
- US
US Agent
- Business Name
- Stryker
- Contact Name
- Shamaila Rafiq
- Address
- 325 Corporate Dr
- City
- Mahwah
- State
- NJ
- ZIP
- 07430
- Country
- US
- [email protected]
- Phone
- 201 3769049
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2021-04-23 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2022-01-31 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2022-01-31 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2012-01-31 |
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
Pangea Utility Plating System
Pangea Platform
Hoffmann 3 Modular External Fixation System
Variax
Pangea Femur Plating System
Pangea Tibia Plating System
Pangea Humerus Plating System
PRO Plating System
Stryker Trauma Pelvic Set (Matta)
AxSOS 3 Ti; Stryker Plating System
VariAx 2 Compression Plating System
Variax Fibula Plate
ORTHOLOC
ORTHOLOC 3Di
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)