FDA Registration Active 🇩🇪 Germany

JOIMAX GMBH

Reg #: 3005083075 · FEI: 3005083075 · Expires 2026
Products
44
Proprietary Names
36
Establishment Types
5
Classifications
44

Registration Details

Registration Name
JOIMAX GMBH
Registration Number
3005083075
FEI Number
3005083075
Status
Active
Expiry Year
2026
Initial Importer
No
Address
AMALIENBADSTRASSE 41, Raumfabrik 61
City
KARLSRUHE Baden-Wurttemberg
Country
DE

Regulatory Submissions

510(k) Number
K151143

Owner / Operator

Firm Name
Joimax GmbH
Operator Number
9070895
Address
Amalienbadstrasse 41, RaumFabrik 61
City
Karlsruhe
State
Baden-Wurttemberg
Postal Code
76227
Country
DE
Correspondent
Wolfgang A Ries

US Agent

Business Name
GSM Services
Contact Name
Gary Mocnik
Address
49 Coastal Oak
City
Aliso Viejo
State
CA
ZIP
92656
Country
US
Phone
949 4330413

Products

Device Name Product Code
Intervertebral Fusion Device With Bone Graft, Lumbar MAX
Forceps, General & Plastic Surgery GEN
Orthosis, Spondylolisthesis Spinal Fixation MNH
Orthosis, Spinal Pedicle Fixation MNI
Thoracolumbosacral Pedicle Screw System NKB
Hammer, Surgical FZY
Arthroscope HRX
Passer, Wire, Orthopedic HXI
Electrosurgical, Cutting & Coagulation & Accessories GEI
Table, Operating-Room, Electrical GDC
Rasp, Surgical, General & Plastic Surgery GAC
Needle, Aspiration And Injection, Disposable GAA
Punch, Surgical LRY
Guide, Needle, Surgical GDF
Instrument, Surgical, Non-Powered HAO
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
Dispenser, Liquid Medication KYX
Tray, Surgical, Instrument FSM
Camera, Surgical And Accessories KQM
Awl HWJ
Cutter, Wire HXZ
Elevator, Surgical, General & Plastic Surgery GEG
Adaptor, Bulbs, Miscellaneous, For Endoscope FFY
Guide, Surgical, Instrument FZX
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
Osteotome, Manual GFI
Accessories, Cleaning Brushes, For Endoscope MNL
Accessories, Arthroscopic NBH
Holder, Needle; Orthopedic HXK
Drape, Surgical, Exempt PUI
Kit, Surgical Instrument, Disposable KDD
Orthopedic Stereotaxic Instrument OLO
Cart, Emergency, Cardiopulmonary (Excluding Equipment) BZN
Curette, Surgical, General Use FZS
Marker, Skin FZZ
Orthopedic Manual Surgical Instrument LXH
Cement, Bone, Vertebroplasty NDN
Reamer HTO
Lavage, Jet FQH
Tape, Measuring, Rulers And Calipers FTY
Camera, Television, Endoscopic, Without Audio FWF
Device, Digital Image Storage, Radiological LMB
Scissors, Orthopedic, Surgical HRR
Table And Attachments, Operating-Room BWN

Proprietary Names

EndoLIF On-Cage TESSYS iLESSYS Percusys® Plus Percusys TESSYS MULTISCOPE joimax Endovapor®2 joimax® Trays & Containers medical screen Elevator EndoLIF(R) Delta-Cage EndoLIF(R) DoubleWedge-Cage Shrill, blades & shafts Osteotome 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® Intracs® System medical trolley joimax® TESSYS® EndoLIF® Kyverment JOIMAX Versicon Twister LED Camsource DUO Vaporflex Legato Vaporace

Establishment Types

Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device Foreign Private Label Distributor