Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009141957

FEI Number

3009141957

Entity Name

AMETEK Poland sp. z o.o.

City/State/Country

Siechnice Dolnoslaskie, PL

Establishment Address

Ul. Stanislawa Staszica 5, Siechnice Dolnoslaskie 55-011, PL

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Paragon Medical (Owner Number: 9011072)

Owner / Operator Contact Address

8 Matchett Dr., --, Pierceton, IN 46562, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 Zimmer Biomet 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 Zimmer Biomet 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 Zimmer Biomet Tap, Locking, AO PERI-LOC IMN Instruments Drill Bit, AO

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2016-06-14
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2013-01-30
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2007-12-28
HTO	Reamer	Orthopedic	Class 1	888.4540	2013-01-17
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2015-01-27
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2025-01-07
PAO	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented	Orthopedic	Class 2	888.3660	2025-01-07
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2025-01-07
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	1994-07-27
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2013-01-30
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2015-06-15
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2015-06-15
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2016-12-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2015-01-27
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2015-01-27
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2017-12-13
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2015-06-15
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2026-06-10
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2015-06-15

Official Correspondent

Stephane Langlois

US Agent Details

Stephane Langlois Business: Paragon Medical Email: stephane.langlois@ametek.com Phone: (435) 5355456

Related Public Records

Same Entity

Paragon Medical

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1834331	PARAGON MEDICAL, INC.	PIERCETON, IN, US
3007539489	Paragon Medical Device (Changzhou) Co., Ltd.	Changzhou Jiangsu, CN
1835831	Paragon Medical Inc.	Castleton, IN, US
1000517406	Paragon Medical Inc.	Smithfield, UT, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K895079	Buckman Co., Inc.	ACE BEADED K-WIRES ACE OLIVE WIRES	1989-09-13
K922193	Osteo AG	OSTEO KIRSCHNER WIRE	1992-07-23
K850026	Kirkstil Corp., Inc.	ORTHOPEDIC IMPLANT NAILS & PINS	1985-05-20
K963367	Rms Div.	RMS K-WIRE	1996-10-30
K040336	Synthes (Usa)	SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM	2004-04-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-05	Biomet, Inc.	2	Lactosorb pin, 2.0 x 20 mm, sterile; ref. 948205.
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009141957. Last updated year: 2026. Please use registration number 3009141957 when referencing this establishment in official correspondence.