Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002976036

FEI Number

3002976036

Entity Name

OURY-GUYE & FILS

City/State/Country

NOGENT Haute-Marne, FR

Establishment Address

31 Rue Malaingre, NOGENT Haute-Marne 52800, FR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

OURY-GUYE & Fils (Owner Number: 10043580)

Owner / Operator Contact Address

31 Rue Malaingre, NOGENT, FR-52 52800, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ancillary set Set Akin (Easyclip 08-10-12) QUANTUM Talar and Insert Implant Holder DISTRACTOR JUDET HAMMER GENERHIP COMPRESSOR BECKMANN RETRACTOR ROD BENDER ROD GRIPPER ESIC ® PRESS Retractor BONE AWL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2013-11-04
KAK	Probe, Ent	Ear, Nose, Throat	Class 1	874.4420	2013-02-28
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2014-04-02
KBJ	Curette, Adenoid	Ear, Nose, Throat	Class 1	874.4420	2015-09-16
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-02-28
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-02-28
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-02-28
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-02-28
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2013-02-28
KCG	Dilator, Tracheal	Ear, Nose, Throat	Class 1	874.4420	2015-09-16
HWT	Template	Orthopedic	Class 1	888.4800	2014-11-17
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	2015-09-16
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	2013-02-28
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-11-04
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2013-02-28
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2013-11-04
HWJ	Awl	Orthopedic	Class 1	888.4540	2022-09-27
KBL	Depressor, Metal Tongue, Surgical	Ear, Nose, Throat	Class 1	874.4420	2013-02-28
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2013-02-28
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	2015-09-16
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-11-04
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2017-03-17
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2013-11-04
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-02-28
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2013-02-28
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2013-11-04
HNI	Retractor, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-02-28
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2014-11-25

Official Correspondent

Hennequin Magalie

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

OURY-GUYE & Fils

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
K012175	Encore Orthopedics, Inc.	PASS SPINAL SYSTEM	2001-07-31
K032752	R&B Surgical Solutions, LLC	R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM	2003-12-03
K062643	Life Spine	KINETIC ANTERIOR CERVICAL PLATE	2006-11-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0036-2013	Medtronic Sofamor Danek USA Inc	2	ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0037-2013	Medtronic Sofamor Danek USA Inc	2	ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0038-2013	Medtronic Sofamor Danek USA Inc	2	PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0040-05	Zimmer Spine, Inc.	2	ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays.
Z-0026-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002976036. Last updated year: 2026. Please use registration number 3002976036 when referencing this establishment in official correspondence.