Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010916

FEI Number

3003569173

Entity Name

Kammerer Medical Systems GmbH & Co. KG

City/State/Country

Stockach Baden-Wurttemberg, DE

Establishment Address

Im Saegenloh 3, Stockach Baden-Wurttemberg D-78333, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Kammerer Medical Systems GmbH & CO. KG (Owner Number: 8010916)

Owner / Operator Contact Address

Im Saegenloh 3, --, Stockach, DE-BW D-78333, DE

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
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2024-11-25
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2024-11-08
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2024-11-08
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2024-11-08
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2024-11-08
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2013-03-22
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2025-12-11
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2025-12-11
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2025-12-11
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2025-12-11
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2025-12-18
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2025-12-18
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-01-30
HWA	Impactor	Orthopedic	Class 1	888.4540	2024-11-25
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2025-12-18
HWB	Extractor	Orthopedic	Class 1	888.4540	2024-11-25
KTW	Appliance, Fixation, Nail/Blade/Plate Combination, Single Component	Orthopedic	Class 2	888.3030	2016-02-03
HRY	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3530	2024-11-08
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2024-11-08
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	1996-12-03
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2013-05-26
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2016-02-03
HXC	Wrench	Orthopedic	Class 1	888.4540	2024-11-08

Official Correspondent

Arian Mingo

US Agent Details

ANGELIKA Scherp Business: BSI BUSINESS SUPPORT INTERNATIONAL Email: info@bsi-fda.com Phone: (212) 3318358

Related Public Records

Same Entity

Kammerer Medical Systems GmbH & CO. KG

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
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-0001-2019	Smith & Nephew, Inc.	2	Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 74021224, 74021225, 74021226, 74021227, 74021228, 74021229
Z-0002-2019	Smith & Nephew, Inc.	2	JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 74021121, 74021122, 74021123, 74021124, 74021125, 74021126, 74021127, 74021128, 74021129, 74021130, 74021131, 74021132, 74021133, 74021134, 74021135, 74021136, 74021137, 74021138, 74021139, 74021140, 74021141, 74021142, 74021143, 74021144, 74021145, 74021146, 74021147, 74021148, 74021149
Z-0003-2017	Zimmer Biomet, Inc.	2	Vanguard 360 Revision Knee System Knee prostheses
Z-0003-2019	Smith & Nephew, Inc.	2	JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 74023121, 74023122, 74023123, 74023124, 74023125, 74023126, 74023127, 74023128, 74023131, 74023132, 74023133, 74023134, 74023135, 74023136, 74023137, 74023138, 74023141, 74023142, 74023143, 74023144, 74023145, 74023146, 74023147, 74023148, 74023211, 74023212, 74023213, 74023214, 74023215, 74023216, 74023217, 74023218, 74023221, 74023222, 74023223, 74023224, 74023225, 74023226, 74023227, 74023228, 74023231, 74023232, 74023233, 74023234, 74023235, 74023236, 74023237, 74023238, 74023241, 74023242, 74023243, 74023244, 74023245, 74023246, 74023247, 74023248, 74023251, 74023252, 74023253, 74023254, 74023255, 74023256, 74023257, 74023258, 74023261, 74023262, 74023263, 74023264, 74023265, 74023266, 74023267, 74023268, 74023271, 74023272, 74023273, 74023274, 74023275, 74023276, 74023277, 74023278, 74023281, 74023282, 74023283, 74023284, 74023285, 74023286, 74023287, 74023288, 74023311, 74023312, 74023313, 74023314, 74023315, 74023316, 74023317, 74023318, 74023321, 74023322, 74023323, 74023324, 74023325, 74023326, 74023327, 74023328, 74023331, 74023332, 74023333, 74023334, 74023335, 74023336, 74023337, 74023338, 74023341, 74023342, 74023343, 74023344, 74023345, 74023346, 74023347, 74023348, 74023411, 74023412, 74023413, 74023414, 74023415, 74023416, 74023417, 74023418, 74023421, 74023422, 74023423, 74023424, 74023425, 74023426, 74023427, 74023428, 74023431, 74023432, 74023433, 74023434, 74023435, 74023436, 74023437, 74023438, 74023441, 74023442, 74023443, 74023444, 74023445, 74023446, 74023447, 74023448, 74023451, 74023452, 74023453, 74023454, 74023455, 74023456, 74023457, 74023458, 74023461, 74023462, 74023463, 74023464, 74023465, 74023466, 74023467, 74023468, 74023471, 74023472, 74023473, 74023474, 74023475, 74023476, 74023477, 74023478, 74023481, 74023482, 74023483, 74023484, 74023485, 74023486, 74023487, 74023488, 74023648, 74203326
Z-0013-06	Plus Orthopedics USA	2	TC-PLUS Tibial Insert Ultra-Congruent Size 10 ; 9 mm, Model 25456

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010916. Last updated year: 2026. Please use registration number 8010916 when referencing this establishment in official correspondence.