Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611579

FEI Number

3002904345

Entity Name

IN'TECH MEDICAL SAS

City/State/Country

RANG DU FLIERS Pas-de-Calais, FR

Establishment Address

93-95 Avenue du Champ de Gretz, RANG DU FLIERS Pas-de-Calais 62180, FR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

IN'TECH MEDICAL SAS (Owner Number: 9044399)

Owner / Operator Contact Address

89 South Commerce Way, Suite 990, Bethlehem, PA 18017, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MF854R Reamer FW774R ROD CALIPER Variable Angle 3mm Hex Driver Variable Angle 4mm Hex Driver Cannulated T7 Driver Shaft, QC Fitting AutoFIX 2/2.5

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2018-06-07
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2013-03-26
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-03-26
HXG	Tamp	Orthopedic	Class 1	888.4540	2014-05-05
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2007-05-24
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2013-03-26
GAC	Rasp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2017-02-28
HTO	Reamer	Orthopedic	Class 1	888.4540	2013-03-26
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2017-04-28
HXW	Bender	Orthopedic	Class 1	888.4540	2013-02-20
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2015-05-22
HWB	Extractor	Orthopedic	Class 1	888.4540	2018-05-29
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2017-01-13
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2018-05-29
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-12-17
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2019-10-25
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2026-05-15
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2026-05-15
HDQ	Dilator, Cervical, Fixed Size	Obstetrics/Gynecology	Class 1	884.4530	2023-05-31
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2023-05-31
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2018-06-07
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2007-05-24
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2023-05-31
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2015-05-22
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2017-04-14
HWN	Instrument, Compression	Orthopedic	Class 1	888.4540	2013-03-26
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2014-05-05
HXE	Fork	Orthopedic	Class 1	888.4540	2025-07-30
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-10-30
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2020-10-15
HXP	Instrument, Bending Or Contouring	Orthopedic	Class 1	888.4540	2013-03-26
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2015-04-10
HWT	Template	Orthopedic	Class 1	888.4800	2013-02-20
FDG	Retractor, Fiberoptic	Gastroenterology, Urology	Class 1	876.4530	2015-05-22
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2013-03-26
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2013-03-26
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2013-03-26
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	2013-02-05
HTE	Elevator	General, Plastic Surgery	Class 1	878.4800	2007-05-24
HXR	Spatula, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2015-05-22
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2020-10-15
KTZ	Caliper	Orthopedic	Class 1	888.4150	2007-05-24
HWJ	Awl	Orthopedic	Class 1	888.4540	2013-03-26
HXC	Wrench	Orthopedic	Class 1	888.4540	2013-02-20
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-08-26

Official Correspondent

Lisa Boyle

US Agent Details

Tania Shammo Business: Bradshaw Medical Inc. - Intech- Exalta Email: tshammo@exalta.com Phone: (262) 2886450

Related Public Records

Same Entity

IN'TECH MEDICAL SAS

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
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02
K881095	CooperVision, Inc.	KOI(TM) INSTRUMENT TRAYS	1988-04-06
K260601	Blue Belt Technologies, Inc.	REAL INTELLIGENCE CORI	2026-03-26
K042598	Zimmer, Inc.	PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES	2004-10-29

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

Similar Registrations

Registration Number	Establishment Name	Location
3017538682	Tri-State Orthopaedics II, LLC	Huntington, WV, US
1834379	MICROPULSE INC	Columbia City, IN, US
3007521480	OrthAlign, Inc.	Irvine, CA, US
1822565	ZIMMER, INC.	WARSAW, IN, US
8010877	KOSCHER & WUERTZ GMBH	SPAICHINGEN Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611579. Last updated year: 2026. Please use registration number 9611579 when referencing this establishment in official correspondence.