Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005083075

FEI Number

3005083075

Entity Name

JOIMAX GMBH

City/State/Country

KARLSRUHE Baden-Wurttemberg, DE

Establishment Address

AMALIENBADSTRASSE 41, Raumfabrik 61, KARLSRUHE Baden-Wurttemberg 76227, DE

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Joimax GmbH (Owner Number: 9070895)

Owner / Operator Contact Address

Amalienbadstrasse 41, RaumFabrik 61, Karlsruhe, DE-BW 76227, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

EndoLIF On-Cage TESSYS iLESSYS Percusys® Plus Percusys iLESSYS TESSYS TESSYS MULTISCOPE joimax Endovapor®2 joimax EndoLIF joimax TESSYS iLESSYS Percusys joimax Percusys TESSYS iLESSYS joimax® Trays & Containers joimax Percusys TESSYS iLESSYS medical screen TESSYS iLESSYS Elevator EndoLIF(R) Delta-Cage EndoLIF(R) DoubleWedge-Cage joimax Percusys iLESSYS TESSYS Shrill, blades & shafts Osteotome joimax shafts, trocars, and obturators for endoscopes JOIMAX (JMSWSNS); JOIMAX (JMSWSNT); JOIMAX (JMSWSNT20); JOIMAX (JMSWSNT23) SPASY (SWMVP); SPASY (SWVP-11A); SPASY (SWVP-11S); SPASY (SWVP-13A) horizontal and vertical drape Intents joimax Joimax® Intracs® System medical trolley iLESSYS TESSYS TESSYS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2015-08-04
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2005-03-25
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2019-12-23
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2019-12-23
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2019-12-23
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2005-03-25
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2006-10-16
HXI	Passer, Wire, Orthopedic	Orthopedic	Class 1	888.4540	2005-03-25
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2017-04-25
GDC	Table, Operating-Room, Electrical	General, Plastic Surgery	Class 1	878.4960	2005-03-25
GAC	Rasp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2015-08-04
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2005-03-25
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2005-03-25
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2005-03-25
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	2005-03-25
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2018-02-13
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2005-05-18
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2005-03-25
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2022-11-17
HWJ	Awl	Orthopedic	Class 1	888.4540	2005-03-25
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	2019-09-20
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2022-11-17
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2021-11-17
FFY	Adaptor, Bulbs, Miscellaneous, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2005-05-18
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2005-03-25
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2010-07-02
GFI	Osteotome, Manual	General, Plastic Surgery	Class 1	878.4800	2014-04-02
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2016-03-10
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2022-11-17
HXK	Holder, Needle; Orthopedic	Orthopedic	Class 1	888.4540	2022-11-17
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2025-03-31
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2005-06-28
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2020-08-24
BZN	Cart, Emergency, Cardiopulmonary (Excluding Equipment)	Anesthesiology	Class 1	868.6175	2022-11-17
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2005-03-25
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2005-03-25

Official Correspondent

Wolfgang Ries

US Agent Details

Gary Mocnik Business: GSM Services Email: gary@gsmservicesus.com Phone: (949) 4330413

Related Public Records

Same Entity

Joimax GmbH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3005042595	JOIMAX, INC.	Irvine, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K223430	Life Spine, Inc.	ProLift Micro Expandable Spacer System	2023-05-04
K102293	Globus Medical, Inc.	CALIBER SPACER	2011-01-05
K193541	Nu Vasive, Incorporated	NuVasive Cohere Thoracolumbar Interbody System	2020-03-30
K080401	Advanced Medical Technologies AG	SHELL CAGE, WAVE CAGE, LOOP CAGE	2008-05-09
K200084	Zavation Medical Products, LLC	Zavation IBF System	2020-10-19

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 3005083075. Last updated year: 2026. Please use registration number 3005083075 when referencing this establishment in official correspondence.