Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9681258

FEI Number

3001354499

Entity Name

AESCULAP SAS

City/State/Country

CHAUMONT Grand Est, FR

Establishment Address

BOULEVARD DU MARECHAL JUIN, BP 2024, CHAUMONT Grand Est 52901, FR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Aesculap AG (Owner Number: 8010193)

Owner / Operator Contact Address

Am Aesculap-Platz, Tuttlingen, DE-BW 78532, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AESCULAP Aesculap

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HWA	Impactor	Orthopedic	Class 1	888.4540	1995-10-11
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	1995-04-26
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2012-11-26

Official Correspondent

Kamaal Anas

US Agent Details

Kamaal Anas Business: Aesculap, Inc. Email: kamaal.anas@bbraunusa.com Phone: (610) 9849071

Related Public Records

Same Entity

Aesculap AG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9610612	AESCULAP AG	TUTTLINGEN, DONAU Baden-Wurttemberg, DE
3008711893	B.Braun Medical (Suzhou) Co,.Ltd	Suzhou Jiangsu, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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
K102380	Wrightmedicaltechnologyinc	EVOLUTION MP TOTAL KNEE SYSTEM	2011-01-07
K122985	Aesculap Implant System, Inc.	COLUMBUS REVISION KNEE SYSTEM	2012-10-26

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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1221934	DePuy Mitek, Inc.	RAYNHAM, MA, US
1000517406	Paragon Medical Inc.	Smithfield, UT, US
3010536692	MICROPORT ORTHOPEDICS INC.	Arlington, TN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9681258. Last updated year: 2026. Please use registration number 9681258 when referencing this establishment in official correspondence.