Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006984710

FEI Number

3006984710

Entity Name

W+S SOLUTIONS GMBH

City/State/Country

Tuttlingen Baden-Wurttemberg, DE

Establishment Address

Industriestr. 5, Tuttlingen Baden-Wurttemberg 78532, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

W+S Solutions GmbH (Owner Number: 10025259)

Owner / Operator Contact Address

Industriestr. 5, Tuttlingen, DE-BW 78532, 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
SFA	Prosthesis, Finger, Semi-Constrained, Metal/Polymer	Unknown	Class 3	N/A	2025-07-22
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-05-05
QWK	Prosthesis, Posterior Spinal Elements	Unknown	Class 3	N/A	2025-05-05
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2022-10-28
PGM	Growing Rod System	Orthopedic	Class 2	888.3070	2026-01-28
HRW	Dynamometer, Nonpowered	Orthopedic	Class 1	888.1250	2023-10-31
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-05-05
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2019-09-05
HWT	Template	Orthopedic	Class 1	888.4800	2019-02-22
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-05-05
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-05-05
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-05-05
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-05-05
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2018-02-22

Official Correspondent

Ulrich Wernz

US Agent Details

Beate Weiss-Krull Business: Beate Weiss-Krull, Attorney at Law Email: bea@weisskrull-law.com Phone: (503) 2340355

Related Public Records

Same Entity

W+S Solutions 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
K260601	Blue Belt Technologies, Inc.	REAL INTELLIGENCE CORI	2026-03-26
K163363	Surgtech, Inc.	SurgTech Thoracolumbosacral (TLS) Posterior Fixation System	2017-04-05
K252461	Spinal Resources, Inc.	Swedge Pedicle Screw Fixation System Bezier Rod	2026-01-13
K140696	Pioneer Surgical Technology, Inc.	STREAMLINE TL SPINAL FIXATION SYSTEM	2014-04-10
K141398	Medicrea International SA	PASS LP SPINAL SYSTEM	2015-01-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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-0001-2013	Synthes USA HQ, Inc.	2	MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
Z-0004-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
Z-0005-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.
Z-0020-06	Pioneer Surgical Technology	2	Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45.

Similar Registrations

Registration Number	Establishment Name	Location
3012494775	HTI TECHNOLOGIES	Decines Rhone, FR
8010099	MEDICON, E.G.	TUTTLINGEN Baden-Wurttemberg, DE
3009540749	Medartis Inc.	Warsaw, IN, US
3010162973	Synergy Health Marseille SAS	MARSEILLE CEDEX 14 Provence-Alpes-Cote d'Azur, FR
3010178296	IONISOS	Dagneux Ain, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006984710. Last updated year: 2026. Please use registration number 3006984710 when referencing this establishment in official correspondence.