FDA Registration
Active
🇵🇱 Poland
AMETEK Poland sp. z o.o.
Reg #: 3009141957
·
FEI: 3009141957
·
Expires 2026
Products
13
Proprietary Names
223
Establishment Types
1
Classifications
13
Registration Details
- Registration Name
- AMETEK Poland sp. z o.o.
- Registration Number
- 3009141957
- FEI Number
- 3009141957
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Ul. Stanislawa Staszica 5
- City
- Siechnice Dolnoslaskie
- Country
- PL
Owner / Operator
- Firm Name
- Paragon Medical
- Operator Number
- 9011072
- Address
- 8 Matchett Dr., --
- City
- Pierceton
- State
- IN
- Postal Code
- 46562
- Country
- US
- Correspondent
- Stephane Langlois
US Agent
- Business Name
- Paragon Medical
- Contact Name
- Stephane Langlois
- Address
- 8 Matchett Dr
- City
- Pierceton
- State
- IN
- ZIP
- 46562
- Country
- US
- [email protected]
- Phone
- 435 5355456
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2016-06-14 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2013-01-30 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2007-12-28 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2013-01-17 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2015-01-27 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2025-01-07 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented | PAO | Class 2 | Orthopedic | No | 2025-01-07 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2025-01-07 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 1994-07-27 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2013-01-30 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2015-01-27 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2015-01-27 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2013-01-30 |
Proprietary Names
Zimmer Biomet
Fluted Pin
Various Drills for Foot Surgery (Twist Drill, Over-Drill, Drill Bit)
Universal Pin
Drill Sleeve Insert
K-Wire Sleeve Insert
Orthopedic Manual Surgical Instrument
LITe Funnel
Bone Tap
Freehand Drill IMN Instruments ø4.2x185mm
Locking Drill IMN Instruments ø4.2x360mm
Trocar SPS-MonoAxial Locking Set 5mm
Inserter sleeve
Freehand Drill IMN Instruments ø3.5x130mm
Drill Sleeve D4.3
"Insertion Sleeve for ø3.2mm Guide Wires"
Depth Gauge 0-120mm
Insert ø3.2 compression
Guide Wire D3xL300
Trocar SPS-MonoAxial Locking Set 4mm
Freehand Drill IMN Instruments ø3.5x185mm
Drill Guide ø6.55
Drilling Guide ø3.2/4.5
Locking Drill IMN Instruments ø3.5x360mm
Depth Gauge 0-70mm for Screws: ø2.7/3.5/4mm
Freehand Drill IMN Instruments ø4.2x130mm
Insert ø2.5 compression
Tissue prot. sleeve ø6.5/4.5
Threaded Guide Wire D3.2xL300 (Sterile)
Screw Insertion Sleeve ø9mm
Lag Screw Tap Sleeve
Drilling Guide ø2.5/3.5
Parallel Drill Guide
Insert ø2.5 neutral
Drill Sleeve Handle
Direct Measuring Gauge
Depth Gauge 0-150mm for Screws: ø4.5/6.5mm
Drill Guide Supracondylar
Lag Screw Depth Gauge
Drill Sleeve D3.1
Depth Gauge 0-110mm For Screws ø2.7/3.5/4
Depth Gauge 0-150mm for Screws: ø2.7/3.5/4mm
Insert ø2.5 support
Drilling Guide ø2/2.7
Drill Gauge (Percutaneous)
Guide Wire D3.2xL300
Threaded Guide Wire D3.2xL300
Guide Wire with Ruler Tube
Insert ø3.2 neutral
Guide Wire D3.2xL300 (Sterile)
Distractor Twist Drill
Centerpiece Plate Fixation System
C-STEM AMT SZ 3A NK SEGMENT
IMN Instruments
C-STEM AMT STD NECK SEGMENT- SZ0/1
INSERTION SHIM - HANDLE
Guide Wire
C-STEM AMT SZ 2A NK SEGMENT
C-STEM AMT HO NECK SEGMENT- SZ4/5
C-STEM AMT HO NECK SEGMENT- SZ 0/1
C-STEM AMT HO NECK SEGMENT- SZ2/3
C-STEM AMT STD NECK SEGMENT- SZ2/3
C-STEM AMT STD NECK SEGMENT- SZ6/7
REAMER DEPTH STOP 10/12MM
GENESIS
The GIRO Growth Modulation System
Free Gliding Slipped Capital Femoral Epiphysis Screw (Scfe)
REAMER DEPTH STOP 8/10MM
AltiVate Anatomic, Humeral Broach, 12mm
AltiVate Anatomic, Humeral Broach, 18mm
AltiVate Anatomic, Humeral Broach, 16mm
AltiVate Anatomic, Humeral Broach, 14mm
AltiVate Anatomic, Humeral Broach, 8mm
AltiVate Anatomic, Humeral Broach, 10mm
Triathlon Primary & MIS Patella Preparation Caddy
Triathlon MIS Femoral Preparation Tray
TS Femoral Augments Trials Tray
TRIATHLON REVISION INSTRUMENTS FEMORAL CONE PREP 1 TRAY
Journey II
Restoration Modular Conical Distal Reamers Tray (10mm-17mm)
TS TCG Insert Trials (Size 1-5, 22-31mm) Tray
RESTORATION MODULAR CONICAL DISTAL STEM TRIALS TRAY 115MM
HINGE FEMORAL TRIALS - LEFT TRAY
Restoration Modular Conical Distal Reamers Tray (18mm-23mm)
Triathlon Pro Miscellaneous Instruments Tray
HINGE TCG TRAY
Revision Finishing Tray
TS Misc. Instruments Tray
TRIATHLON REVISION INSTRUMENTS TIBIAL CONE UPPER TRAY
TRIDENT TRITANIUM INSERT TRIALS TRAY
Hinge Insert Trials Tray
TS Insert Trials (9-19mm) Tray
Revision Tibial Prep Tray
Revision IM Reamers (20-25mm) Tray
FEMORAL AUGMENT TRIALS AND DISTAL SPACERS CADDY
Triathlon 5511 PS Femoral Trials Tray - Left
TS Femoral Trials - Left Tray
Trident II Reamers (38-66mm) Tray
TS Femoral Trials - Right Tray
TRIATHLON PRO PS BOX REAM PREPARATION TRAY
Triathlon Pro PS Insert Trials Tray (Size 0-7)
Femoral Distal Spacers Caddy
REVISION BASEPLATE FINISHING TRAY
Triathlon Primary & MIS Patella Preparation Tray
TS Universal Baseplate Finishing Tray
TRIATHLON PRO MISCELLANEOUS INSTRUMENTS TRAY WITH CR PATELLA TRACK TRIALS
Femoral Distal Augment Trials (Size 1-4) Caddy
Offset Reamer Handle Tray
Trident Tritanium Window Trials Tray
Accolade II Broach Tray
Accolade II Basic Tray
Trident II Core Reamers (38-66mm) Tray
Acetabular Reamers (67-80)mm Tray
Trident Window Trials Tray
Tritanium Window Trials Tray
Trident II Auxiliary Trials Tray
Acetabular Reamers (36-66)mm Tray
Trident Constrained Insert Trials Tray
Trident II General Instruments Tray
Exeter Retractor Tray
Trident II Core Trials Tray
Modular Dual Mobility Tray
MIS TKA IM LID
General Femoral Tray
LCCK ART SURFACE PROV CASE
LCCK STEM PROV BASE, FLUTED
ELEOS INSTRUMENTATION TRAY, TRAY LID STANDARD
ELEOS INSTRUMENTATION TRAY, MALE-MALE MIDSECTION TRIALS, TRAY 12
LCCK STEM PROV CASE, STR/OFS
Exeter Broach Tray
ELEOS INSTRUMENTATION TRAY, RESURFACING STEM TRIALS, TRAY 5
ELEOS INSTRUMENTATION TRAY, PATELLA INSTRUMENTS, TRAY 10
Exeter Extension Broach Tray
ELEOS INSTRUMENTATION TRAY, FEMORAL RESURFACING INSTRUMENTS, TRAY 9
Exeter Plug Trial Tray
Triathlon Tritanium Central Femoral Cone Preparation Tray
ELEOS INSTRUMENTATION TRAY, GENERAL RESURFACING INSTRUMENTS, TRAY 8
ELEOS INSTRUMENTATION TRAY, TIBIAL RESURFACING TRIALS, TRAY 6
LCCK BLOCK AUGMENT PROV BASE
WalterLorenz Surgical Assist Arm
ELEOS INSTRUMENTATION TRAY, AUGMENT PREPARATION AND TRIALING INSTRUMENTS, TRAY 13
ELEOS INSTRUMENTATION TRAY, PROXIMAL TIBIA TRIALS, TRAY 11
LCCK FEM AUG & BOX PROV TRAY
Tray, Surgical, Instrument
LCCK FEM CUTTING INST CASE
ELEOS INSTRUMENTATION TRAY, PIN CADDY, KIT TO TRAY 8
GENERIC STACKABLE LID ASSY
LCCK REAMER BASE W/ T-HANDLE
ELEOS INSTRUMENTATION TRAY, SEGMENTAL STEM TRIALS, TRAY 3
NEXGEN FEM RESECT BASE ASSY
ELEOS INSTRUMENTATION TRAY, PROXIMAL DISTAL FEMORAL SEGMENTAL TRIALS, TRAY 4
ELEOS INSTRUMENTATION TRAY, REAMERS, TRAY 1
ELEOS INSTRUMENTATION TRAY, TIBIAL RESURFACING PREPARATION INSTRUMENTS, TRAY 7
ELEOS INSTRUMENTATION TRAY, ASSEMBLY/DISASSEMBLY INSTRUMENTS, TRAY 2
ELEOS INSTRUMENTATION TRAY, TRAY LID SMALL
STERILIZATION TRAY TIB TM CONE
A.L.P.S. Clavicle Plating System
VPC Instruments
STERILIZATION BASE TIB TM CONE
VIPER PRIME CFXFEN XTAB TRAY 2
Persona Modular Case Component
Persona Modular Case Componet
PRIMARY DELIVERY SYS
VIPER PRIME SCREW CADDY
VIPER PRIME CFXFEN X-TAB TRAY
SR LID BASE ASSEMBLY BASE
Restoration Modular Conical Distal Reamers Tray (24mm-28mm)
Triathlon Pro 4IN1's & Spacer Blocks Tray
Triathlon Pro Patella Preparation Caddy
HINGE FEMORAL PREP TRAY
SR LID BASE ASSEMBLY LID
PRIME TOP IMPLANT TRAY
Triathlon Pro Femoral Trials Tray - Right
Triathlon Pro CS Insert Trials Tray (Size 0-7)
TS TCG Insert Trials (Size 6-8, 22-31mm) Tray
TRIATHLON INSERT TRIAL TRAY-CS(SIZE 1-8)
TRIATHLON INSERT TRIAL TRAY-CR(SIZE 1-8)
TS Insert Trials (size 1-5, 22-31mm) Tray
TRIATHLON REVISION INSTRUMENTS FEMORAL CONE PREP 2 TRAY
Universal Lid
Triathlon Primary/Express/MIS Tibial Preparation Tray
Revision General Tray
HINGE FEMORAL TRIALS - RIGHT TRAY
Femoral Posterior Augment Trials (Size 1-8) Caddy
Revision IM Reamers (8-19mm) Tray
Femoral Distal Augment Trials (Size 5-8) Caddy
Triathlon PS Box Cutting Guides Tray
TS Femoral Prep Tray
Triathlon Pro Femoral Trials Tray - Left
Triathlon Pro CR Insert Trials Tray (Size 0-7)
Revision 100mm Stem Trials (9-25mm) Tray
Revision 150mm Stem Trials (9-25mm) Tray
Offset Adapter Trials Caddy
ETS Instrument Tray
Triathlon Pro Miscellaneous Instruments Caddy
RESTORATION MODULAR GENERAL INSTRUMENTS TRAY
TS Insert Trials (size 6-8, 22-31mm) Tray
TRIATHLON REVISION INSTRUMENTS TIBIAL CONE LOWER TRAY
Z1 Hip System
Restoration Modular Proximal Cone Reamers Tray (19mm-31mm)
Triathlon Pro Tibial Preparation Tray
Restoration Modular Auxiliary Instruments Tray
TS TCG Tray
Restoration Modular Conical Distal Stem Trials Tray 155mm
Triathlon Pro Patella Preparation Tray
Triathlon Primary & Express Femoral Preparation Tray
Restoration Modular Extraction Instruments Tray
TS TCG Insert Trials (9-19mm) Tray
TRIATHLON INSERT TRIAL TRAY-PS(SIZE 1-8)
Triathlon 5511 PS Femoral Trials Tray - Right
Intermediate
Tap, Locking, AO
PERI-LOC
Drill Bit, AO
Graft Sizer
SharpShooter Cannula Right Middle
SharpShooter Cannula Right Posterior
CMI Delivery Clamp
CMI Measuring Cannula
SharpShooter Cannula Left Middle
SharpShooter Cannula Right Anterior
SharpShooter Cannula Left Anterior
SharpShooter Cannula Left Posterior
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)