Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017406274

FEI Number

3017406274

Entity Name

RIWOSPINE GMBH

City/State/Country

Knittlingen Baden-Wurttemberg, DE

Establishment Address

Pforzheimer Strasse 32, Knittlingen Baden-Wurttemberg 75438, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

RIWOspine GmbH (Owner Number: 10093852)

Owner / Operator Contact Address

Pforzheimer Strasse 32, Knittlingen, DE-BW 75438, 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
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2025-07-22
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-07-23
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2025-07-23
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2026-01-27
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2026-01-27
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2026-01-27

Official Correspondent

Nico Dr. Braunegger

US Agent Details

Franz Menean Business: MEDAGENT Inc. Email: mail@medagent-usa.com Phone: (603) 5702029

Related Public Records

Same Entity

RIWOspine 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-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.
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-0013-05	Biomet, Inc.	2	Lactosorb pin, 2.0 x 20 mm, sterile; ref. 948205.

Similar Registrations

Registration Number	Establishment Name	Location
3014725904	Medtronic Medical Costa Rica S.R.L.	Coyol Alajuela, CR
3040335671	Stryker Ireland Ltd. Instruments Division, Innovation Centre	Carrigtwohill Cork (County), IE
3010363503	FRUEH VERPACKUNGSTECHNIK AG	Fehraltorf Zurich, CH
3010287737	BAECHLER FEINTECH AG	Hoelstein Basel-Landschaft, CH
3010673850	MK medical GmbH	Emmingen-Liptingen Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017406274. Last updated year: 2026. Please use registration number 3017406274 when referencing this establishment in official correspondence.