Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006561161

FEI Number

3006561161

Entity Name

Hoogland Spine Products GmbH

City/State/Country

Unterfoehring Munich Bavaria, DE

Establishment Address

Feringastr. 4, Unterfoehring Munich Bavaria 85774, DE

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Hoogland Spine Products GmbH (Owner Number: 10023561)

Owner / Operator Contact Address

Feringastr. 4, Unterfoehring Munich, DE-BY 85774, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

maxmore Smart Pack System BD Quincke Spinal Needle MaxMore TOM painless hammer maxMore bone drill manual Sterile Spinal Needle - 18G maxMore cleaning brush maxMore metal ruler Needle Placer maxMore TOMshidi needle sealing cap maxMore TOM Stick Endoscope Container small 1/2 maxMore dilator small wrench MaxMoreSpine TOM Stick maxMore grasping forceps

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FWL	Camera, Cine, Endoscopic, Without Audio	General, Plastic Surgery	Class 1	878.4160	2023-05-23
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2023-06-06
LXI	Guide, Drill, Ligament	General, Plastic Surgery	Class 1	878.4820	2017-11-23
GFG	Bit, Surgical	General, Plastic Surgery	Class 1	878.4820	2017-11-23
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2007-12-03
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2007-12-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-07-28
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2023-06-06
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2007-12-03
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2017-11-23
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2007-12-03
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2021-07-14
HRR	Scissors, Orthopedic, Surgical	Orthopedic	Class 1	888.4540	2021-07-14
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-02-01
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2007-12-03
HXI	Passer, Wire, Orthopedic	Orthopedic	Class 1	888.4540	2007-12-03
HXB	Probe	Orthopedic	Class 1	888.4540	2009-02-10
EIE	Dam, Rubber	Dental	Class 1	872.6300	2007-12-03
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2007-12-03
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2008-07-29
HTO	Reamer	Orthopedic	Class 1	888.4540	2008-07-29
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2018-01-16
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2007-12-03
HXC	Wrench	Orthopedic	Class 1	888.4540	2007-12-03
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2011-03-17
GEY	Motor, Surgical Instrument, Ac-Powered	General, Plastic Surgery	Class 1	878.4820	2017-11-23
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2021-07-21
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2017-11-23
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2021-07-14
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2011-03-17
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2007-12-03
HXK	Holder, Needle; Orthopedic	Orthopedic	Class 1	888.4540	2008-08-29
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2007-12-03

Official Correspondent

Jaap Hoogland

US Agent Details

Kenneth Kleinhenz Business: QSR Consulting Email: kleinhenz64@gmail.com Phone: (619) 2449573

Related Public Records

Same Entity

Hoogland Spine Products 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
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0040-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 3mm Offset (Blue) Catalog Number: 72201713 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0041-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 4mm Offset (Purple Catalog Number: 72201714 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0042-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 5mm Offset (Red) Catalog Number: 72201715 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0043-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 6mm Offset (Green) Catalog Number: 72201716 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006561161. Last updated year: 2026. Please use registration number 3006561161 when referencing this establishment in official correspondence.