Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9615014

FEI Number

3005568854

Entity Name

OSARTIS GMBH

City/State/Country

Muenster Hesse, DE

Establishment Address

Auf der Beune 101, Muenster Hesse 64839, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

OSARTIS GmbH (Owner Number: 10055041)

Owner / Operator Contact Address

Auf der Beune 101, Muenster, DE-HE 64839, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BonOs HV Genta Versabond BonOs Inject BonOs R Genta Vertecem II Mixing Kit BIOWASH Surgical Irrigation XPERIENCE Advanced Surgical Irrigation MixOR BonOs R BonOs HV

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2024-03-25
MBB	Bone Cement, Antibiotic	Orthopedic	Class 2	888.3027	2024-03-25
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2018-06-12
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2017-05-29
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2021-07-13
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2021-07-13
PML	Bone Cement, Posterior Screw Augmentation	Orthopedic	Class 2	888.3027	2021-07-13
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2021-07-13
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2017-05-29
MBB	Bone Cement, Antibiotic	Orthopedic	Class 2	888.3027	2017-05-29
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2017-05-29
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2017-05-29
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2026-02-09
JDZ	Mixer, Cement, For Clinical Use	Orthopedic	Class 1	888.4210	2017-05-29
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2017-05-29
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2024-05-03
JDY	Evacuator, Vapor, Cement Monomer	Orthopedic	Class 1	888.4220	2022-10-21
KIH	Dispenser, Cement	Orthopedic	Class 1	888.4200	2022-10-21

Official Correspondent

Volker Stirnal

US Agent Details

Christine L. Brauer Business: Brauer Device Consultants, LLC Email: chris.brauer@comcast.net Phone: (301) 5451990

Related Public Records

Same Entity

OSARTIS 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
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
K160980	Spineology, Inc.	Threshold Pedicular Fixation System, Palisade Pedicular Fixation System	2016-05-26

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.

Similar Registrations

Registration Number	Establishment Name	Location
3013186738	Heraeus Medical LLC	Yardley, PA, US
9616671	DEPUY (IRELAND)	CO. CORK Munster, IE
3015207155	Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai, CN
9612420	ULRICH GMBH & CO. KG	ULM Baden-Wurttemberg, DE
9610726	HOWMEDICA INTERNATIONAL S. DE R.L.,	LIMERICK Munster, IE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615014. Last updated year: 2026. Please use registration number 9615014 when referencing this establishment in official correspondence.