Data / Medical devices / Germany / Spinendos GmbH

Spinendos GmbH: FDA-registered device maker in Muenchen Bavaria, Germany, 1 510(k) clearance

Name: Spinendos GmbH FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Spinendos GmbH is registered with the FDA (registration 3009499159) in Muenchen Bavaria, Germany. It lists 23 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 14, 2014. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3009499159
Address: Landsberger Strasse 398, Muenchen Bavaria, Germany, 81241
Owner or operator: Spinendos GmbH (10038995)
Roles: Repackager or relabeler
First device listed: December 1, 2011
Registered through: 2026
Brand names listed: Cercival Endoscope, Discoscope, Instrument Tray

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Arthroscopic	NBH	1	Repackager or relabeler	accessdata.fda.gov
Arthroscope	HRX	2	Repackager or relabeler	accessdata.fda.gov
Awl	HWJ	1	Repackager or relabeler	accessdata.fda.gov
Camera, Television, Endoscopic, Without Audio	FWF	1	Repackager or relabeler	accessdata.fda.gov
Cannula, Surgical, General & Plastic Surgery	GEA	1	Repackager or relabeler	accessdata.fda.gov
Chisel, Surgical, Manual	FZO	1	Repackager or relabeler	accessdata.fda.gov
Curette	HTF	1	Repackager or relabeler	accessdata.fda.gov
Dissector, Surgical, General & Plastic Surgery	GDI	1	Repackager or relabeler	accessdata.fda.gov
Forceps	HTD	1	Repackager or relabeler	accessdata.fda.gov
Guide, Surgical, Instrument	FZX	1	Repackager or relabeler	accessdata.fda.gov
Holder, Needle; Orthopedic	HXK	1	Repackager or relabeler	accessdata.fda.gov
Hook, Surgical, General & Plastic Surgery	GDG	1	Repackager or relabeler	accessdata.fda.gov
Knife, Surgical	EMF	1	Repackager or relabeler	accessdata.fda.gov
Mallet	HXL	1	Repackager or relabeler	accessdata.fda.gov
Probe	HXB	1	Repackager or relabeler	accessdata.fda.gov
Punch, Surgical	LRY	1	Repackager or relabeler	accessdata.fda.gov
Rasp	HTR	1	Repackager or relabeler	accessdata.fda.gov
Retractor	GAD	1	Repackager or relabeler	accessdata.fda.gov
Rongeur	HTX	1	Repackager or relabeler	accessdata.fda.gov
Scissors, General, Surgical	LRW	1	Repackager or relabeler	accessdata.fda.gov
Syringe, Irrigating (Non Dental)	KYZ	1	Repackager or relabeler	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Repackager or relabeler	accessdata.fda.gov
Trephine	HWK	1	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
April 14, 2014	K130778	DISCOSCOPES, CERVICAL ENDOSCOPES	HRX	Substantially Equivalent	Rz Medizintechnik GmbH	accessdata.fda.gov

Compare with other makers

Updated April 14, 2014. 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.