Data / Medical devices / Germany / Z-Medical GMBH & Co. KG

Z-Medical GMBH & Co. KG: FDA-registered device maker in Tuttlingen Baden-Wurttemberg, Germany, 3 510(k) clearances

Name: Z-Medical GMBH & Co. KG FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Z-Medical GMBH & Co. KG is registered with the FDA (registration 3009110133) in Tuttlingen Baden-Wurttemberg, Germany. It lists 14 device types. The FDA files 3 510(k) clearances under its listings, the newest dated February 3, 2015. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3009110133
Address: Gansacker 38, Tuttlingen Baden-Wurttemberg, Germany, 78532
Owner or operator: Z-MEDICAL GMBH & CO. KG (10036391)
Roles: Exporter to the US, Manufacturer, Repackager or relabeler
First device listed: May 5, 2011
Registered through: 2027

Devices it lists

Device	Product code	Class	Role	Source
Burr, Orthopedic	HTT	1	Manufacturer	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Instrument, Microsurgical	GZX	1	Manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Orthosis, Spinal Pedicle Fixation	MNI	2	Manufacturer	accessdata.fda.gov
Orthosis, Spondylolisthesis Spinal Fixation	MNH	2	Manufacturer	accessdata.fda.gov
Pin, Fixation, Smooth	HTY	2	Manufacturer	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Manufacturer	accessdata.fda.gov
Screwdriver	HXX	1	Manufacturer	accessdata.fda.gov
Staple, Fixation, Bone	JDR	2	Manufacturer	accessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	KCT	2	Exporter to the US	accessdata.fda.gov
Thoracolumbosacral Pedicle Screw System	NKB	2	Manufacturer	accessdata.fda.gov
Tray, Surgical	LRP	1	Manufacturer	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 3, 2015	K143200	MIS Z-Pedicle Screw System	NKB	Substantially Equivalent	Z-Medical GmbH & Co. KG	accessdata.fda.gov
July 5, 2013	K123234	ERMIS STERILIZATION CONTAINER SYSTEM	KCT	Substantially Equivalent	Ermis Medizintechnik	accessdata.fda.gov
November 7, 2012	K121277	Z-SNAP OFF SCREW, Z-DOUBLE THREAD COMPRESSION SCREW, Z-GUIDE WIRE, Z-STAPLE	HWC	Substantially Equivalent	Z-Medical GmbH & Co. KG	accessdata.fda.gov

Compare with other makers

Updated February 3, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.