Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3023265483

FEI Number

3023265483

Entity Name

PHEN'X TECHNOLOGIES

City/State/Country

Chassieu Auvergne-Rhone-Alpes, FR

Establishment Address

7B rue Lavoisier, Chassieu Auvergne-Rhone-Alpes 69680, FR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Phen'X Technologies (Owner Number: 10085595)

Owner / Operator Contact Address

7B rue Lavoisier, Chassieu, FR-ARA 69680, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Neofuse PSI DUAFIT IBS-C/N QUANTUM NEOFUSE IBS-C/N TRIWAY Neomis single use kit TRIWAY IBS-C/N

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2025-05-06
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2022-07-28
HWA	Impactor	Orthopedic	Class 1	888.4540	2022-07-27
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-08-01
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2022-07-27
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2022-07-07
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2022-07-27
HTO	Reamer	Orthopedic	Class 1	888.4540	2022-07-28
KIL	Positioner, Socket	Orthopedic	Class 1	888.4540	2022-07-27
GFG	Bit, Surgical	General, Plastic Surgery	Class 1	878.4820	2022-07-27
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2024-02-21
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2024-02-21
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2024-02-21
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2025-05-05
HYA	Forceps, Wire Holding	General, Plastic Surgery	Class 1	878.4800	2025-06-12
HWD	Starter, Bone Screw	Orthopedic	Class 1	888.4540	2022-07-27

Official Correspondent

Natalie Kennel

US Agent Details

Natalie Kennel Business: NJK & Associates Email: nkennel@njkconsulting.com Phone: (858) 7050350

Related Public Records

Same Entity

Phen'X Technologies

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
K042598	Zimmer, Inc.	PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES	2004-10-29
K190842	Jiangsu Trauhui Medical Instrument Co., Ltd.	Comus Locking Plate systems	2020-02-03
K130510	Arthrex, Inc.	ARTHREX COMPRESSION PLATES	2013-09-25
K202803	Newclip Technics	Activmotion S DTO	2021-12-16
K012175	Encore Orthopedics, Inc.	PASS SPINAL SYSTEM	2001-07-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2008	N/A	1	EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.
Z-0034-2022	Flower Orthopedics Corporation	2	Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0021-2015	Biomet, Inc.	1	Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.
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 3023265483. Last updated year: 2026. Please use registration number 3023265483 when referencing this establishment in official correspondence.