Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009110133

FEI Number

3009110133

Entity Name

Z-MEDICAL GMBH & CO. KG

City/State/Country

Tuttlingen Baden-Wurttemberg, DE

Establishment Address

Gansacker 38, Tuttlingen Baden-Wurttemberg 78532, DE

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

Z-MEDICAL GMBH & CO. KG (Owner Number: 10036391)

Owner / Operator Contact Address

Gansacker 38, 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
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2011-05-05
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2015-02-06
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2015-02-06
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2015-02-06
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-11-15
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2012-11-15
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2012-11-15
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2015-02-06
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2011-05-05
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2011-05-05

Official Correspondent

Zbigniew Combrowski

US Agent Details

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

Related Public Records

Same Entity

Z-MEDICAL GMBH & CO. KG

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
K032604	Co-Ligne AG	GII SPINAL FIXATION SYSTEM	2004-01-20
K964304	Osteonics Corp.	OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY	1997-01-17
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
Z-0021-06	Pioneer Surgical Technology	2	Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog number 10-575-PA-40.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009110133. Last updated year: 2026. Please use registration number 3009110133 when referencing this establishment in official correspondence.