Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009499159

FEI Number

3009499159

Entity Name

Spinendos GmbH

City/State/Country

Muenchen Bavaria, DE

Establishment Address

Landsberger Strasse 398, Muenchen Bavaria 81241, DE

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Spinendos GmbH (Owner Number: 10038995)

Owner / Operator Contact Address

Landsberger Strasse 398, Muenchen, DE-BY 81241, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Discoscope Cercival Endoscope Instrument Tray

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTX	Rongeur	Orthopedic	Class 1	888.4540	2011-12-01
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2011-12-01
FWF	Camera, Television, Endoscopic, Without Audio	General, Plastic Surgery	Class 1	878.4160	2011-12-01
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2011-12-01
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2014-04-17
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2011-12-01
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2011-12-01
HXK	Holder, Needle; Orthopedic	Orthopedic	Class 1	888.4540	2011-12-01
HXB	Probe	Orthopedic	Class 1	888.4540	2011-12-01
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2011-12-01
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2011-12-01
HWJ	Awl	Orthopedic	Class 1	888.4540	2011-12-01
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2011-12-01
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2018-05-16
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2011-12-01
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2011-12-01
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2011-12-01

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

Spinendos 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
K081051	Spine View, Inc.	SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE	2008-08-07
K820777	The Anspach Effort, Inc.	MINI-MICRO ARTHROSCOPIC SCAPEL	1982-05-12
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05
K760422	Cutter Laboratories, Inc.	SURGICAL RETRACTOR	1976-08-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

Similar Registrations

Registration Number	Establishment Name	Location
3043008835	STARK SURGICAL INSTRUMENTS	Moorpark, CA, US
3006128100	Nemcomed FW LLC	FORT WAYNE, IN, US
1226544	MILLSTONE MEDICAL OUTSOURCING LLC.	FALL RIVER, MA, US
3011577940	Titan Spine, a Division of Medtronic	Milwaukee, WI, US
3007648354	FETZER MEDICAL GMBH & CO.KG	Tuttlingen Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009499159. Last updated year: 2026. Please use registration number 3009499159 when referencing this establishment in official correspondence.