Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9615766

FEI Number

3003690049

Entity Name

LISI MEDICAL FASTENERS

City/State/Country

MIRIBEL CEDEX Auvergne-Rhone-Alpes, FR

Establishment Address

19 CHEMIN DE LA TRAILLE, NEYRON-B.P. 100, MIRIBEL CEDEX Auvergne-Rhone-Alpes 01701, FR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

PRECERA MEDICAL NEYRON SAS (Owner Number: 10094627)

Owner / Operator Contact Address

19 CHEMIN DE LA TRAILLE, NEYRON, FR-ARA 01700, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-12-11
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-12-11
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-12-11
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-12-11

Official Correspondent

Angelique Hamon

US Agent Details

Claire BROWN Email: claire.brown@preceramedical.com Phone: (763) 2302935

Related Public Records

Same Entity

PRECERA MEDICAL NEYRON 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
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
K163363	Surgtech, Inc.	SurgTech Thoracolumbosacral (TLS) Posterior Fixation System	2017-04-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0034-2022	Flower Orthopedics Corporation	2	Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Z-0001-2013	Synthes USA HQ, Inc.	2	MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
Z-0004-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
Z-0005-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.
Z-0020-06	Pioneer Surgical Technology	2	Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45.

Similar Registrations

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3022777867	FIXIER S.A. DE C.V.	Doctor Mora Guanajuato, MX
3017209758	NEBULA SURGICAL PRIVATE LIMITED	Rajkot Gujarat, IN
3017609305	PRIMEMED INC.	Sungnam-city Gyeonggi, KR
3015410662	Jabil Inc. (Wilson Drive)	W Chester, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615766. Last updated year: 2026. Please use registration number 9615766 when referencing this establishment in official correspondence.