Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004915132

FEI Number

3004915132

Entity Name

AMF, Sarl

City/State/Country

Lury sur Arnon Cher, FR

Establishment Address

14, Route de Quincy, Lury sur Arnon Cher F-18120, FR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

AMF, Sarl (Owner Number: 10040653)

Owner / Operator Contact Address

Route de Quincy, Lury sur Arnon, FR-18 F-18120, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Nitinol Alloy 2 legs tepid memory staple Novastep Memo Staple Arcad compressive osteosynthesis staples Nitinol Alloy 2 legs cold memory staple Nitinol Alloy 4 legs tepid memory staple

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2012-05-03
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2017-05-12
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2017-02-13
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2017-02-13
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2014-02-06
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2012-05-03

Official Correspondent

Philippe Marx

US Agent Details

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

Related Public Records

Same Entity

AMF, Sarl

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
K153770	In2bones Sas	OS2(R)-VP Varisation Staple	2016-03-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2023	Synthes (USA) Products LLC	2	Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001

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3014527966	F & A FOUNDATION	Tulsa, OK, US
1833920	INSTRU-MED TECHNOLOGIES	Warsaw, IN, US
1058584	Sterigenics US LLC	Charlotte, NC, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004915132. Last updated year: 2026. Please use registration number 3004915132 when referencing this establishment in official correspondence.