Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013194153

FEI Number

3013194153

Entity Name

ARMBRUSTER GMBH

City/State/Country

Steinach Baden-Wurttemberg, DE

Establishment Address

Josef-Maier-Str. 6, Steinach Baden-Wurttemberg 77790, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Armbruster GmbH (Owner Number: 10054478)

Owner / Operator Contact Address

Josef-Maier-Str. 6, Steinach, DE-BW 77790, 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
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-04-29
HXC	Wrench	Orthopedic	Class 1	888.4540	2019-05-27
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2019-05-16
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2019-05-27
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-11-14
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2020-03-03
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2025-04-29
HWJ	Awl	Orthopedic	Class 1	888.4540	2019-05-27
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2019-07-18
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2025-01-31
OQI	Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented	Orthopedic	Class 2	888.3353	2025-01-31
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2019-06-21
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-11-14
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2025-01-30
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-01-26
PLF	Bone Wedge	Orthopedic	Class 2	888.3030	2023-01-26
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2017-03-23
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2017-05-30
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2023-11-07
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2019-02-12
GFC	Driver, Surgical, Pin	General, Plastic Surgery	Class 1	878.4820	2023-03-16
HWB	Extractor	Orthopedic	Class 1	888.4540	2025-01-30
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2018-02-21
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2025-01-30
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2025-01-30
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2025-01-30
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-10-13
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2022-12-19
KQW	Goniometer, Nonpowered	Orthopedic	Class 1	888.1520	2025-01-30
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2025-01-30
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2025-01-30
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2025-02-03
HTQ	Broach	Orthopedic	Class 1	888.4540	2025-01-31
HWA	Impactor	Orthopedic	Class 1	888.4540	2019-05-27

Official Correspondent

No official correspondent registered.

US Agent Details

Franz Menean Business: MEDAGENT Inc. Email: mail@medagent-usa.com Phone: (603) 5702039

Related Public Records

Same Entity

Armbruster GmbH

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
K192492	Astura Medical, LLC	EL CAPITAN Anterior Lumber Interbody System	2020-04-21

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-0041-2024	Blue Belt Technologies, Inc	2	Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Z-0036-2013	Medtronic Sofamor Danek USA Inc	2	ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0037-2013	Medtronic Sofamor Danek USA Inc	2	ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0038-2013	Medtronic Sofamor Danek USA Inc	2	PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013194153. Last updated year: 2026. Please use registration number 3013194153 when referencing this establishment in official correspondence.