Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009590742

FEI Number

3009590742

Entity Name

AMPLITUDE

City/State/Country

Valence Drome, FR

Establishment Address

11 Cours Jacques Offenbach, Zone Mozart 2, Valence Drome 26000, FR

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

AMPLITUDE (Owner Number: 10054515)

Owner / Operator Contact Address

11 Cours Jacques Offenbach, ZA Mozart 2, Valence, FR-26 26000, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Punch Driver Impactor Template for Clinical Use Forceps Surgical instruments Probe TOWNLEY Caliper 115 mm Wrench Chisel Drill bit Guide Surgical instrument Anatomic Total Knee System Retractor Extractor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2017-03-29
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2017-03-29
HWA	Impactor	Orthopedic	Class 1	888.4540	2017-03-29
HWT	Template	Orthopedic	Class 1	888.4800	2017-12-15
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2017-03-29
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2017-03-29
HXB	Probe	Orthopedic	Class 1	888.4540	2017-03-29
KTZ	Caliper	Orthopedic	Class 1	888.4150	2017-12-21
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2023-11-27
HXC	Wrench	Orthopedic	Class 1	888.4540	2017-03-29
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2017-03-29
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2017-03-28
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2017-03-29
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2017-03-29
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2017-03-28
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2017-03-29
HWB	Extractor	Orthopedic	Class 1	888.4540	2017-03-28

Official Correspondent

Mireille Lemery

US Agent Details

Emily Matorin Business: FDAbasics Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

AMPLITUDE

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
K901338	Kirschner Medical Corp.	KIRSCHNER MODULAR TCIV TOTAL KNEE SYSTEM	1990-05-22
K030577	Stelkast Company	PROVEN MODULAR TIBIAL TRAY	2003-03-25
K153310	Total Joint Orthopedics, Inc.	Klassic Knee System	2015-12-17

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-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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009590742. Last updated year: 2026. Please use registration number 3009590742 when referencing this establishment in official correspondence.