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
- [email protected]
- Phone
- 949 4330413
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2015-08-04 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2005-03-25 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2019-12-23 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2019-12-23 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2019-12-23 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2005-03-25 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2006-10-16 |
| Passer, Wire, Orthopedic | HXI | Class 1 | Orthopedic | No | 2005-03-25 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2017-04-25 |
| Table, Operating-Room, Electrical | GDC | Class 1 | General, Plastic Surgery | No | 2005-03-25 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 2015-08-04 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2005-03-25 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2005-03-25 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2005-03-25 |
| Instrument, Surgical, Non-Powered | HAO | Class 1 | Neurology | No | 2005-03-25 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2018-02-13 |
| Dispenser, Liquid Medication | KYX | Class 1 | General Hospital | No | 2005-05-18 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2005-03-25 |
| Camera, Surgical And Accessories | KQM | Class 1 | General, Plastic Surgery | No | 2022-11-17 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2005-03-25 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 2019-09-20 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 2022-11-17 |
| Adaptor, Bulbs, Miscellaneous, For Endoscope | FFY | Class 1 | Gastroenterology, Urology | No | 2005-05-18 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2005-03-25 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2010-07-02 |
| Osteotome, Manual | GFI | Class 1 | General, Plastic Surgery | No | 2014-04-02 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 2016-03-10 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2022-11-17 |
| Holder, Needle; Orthopedic | HXK | Class 1 | Orthopedic | No | 2022-11-17 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2025-03-31 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2005-06-28 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2020-08-24 |
| Cart, Emergency, Cardiopulmonary (Excluding Equipment) | BZN | Class 1 | Anesthesiology | No | 2022-11-17 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2005-03-25 |
| Marker, Skin | FZZ | Class 1 | General, Plastic Surgery | No | 2005-03-25 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2005-05-18 |
| Cement, Bone, Vertebroplasty | NDN | Class 2 | Orthopedic | No | 2012-08-16 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2005-03-25 |
| Lavage, Jet | FQH | Class 2 | General Hospital | No | 2005-03-25 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2005-03-25 |
| Camera, Television, Endoscopic, Without Audio | FWF | Class 1 | General, Plastic Surgery | No | 2005-03-25 |
| Device, Digital Image Storage, Radiological | LMB | Class 1 | Radiology | No | 2005-03-25 |
| Scissors, Orthopedic, Surgical | HRR | Class 1 | Orthopedic | No | 2015-08-14 |
| Table And Attachments, Operating-Room | BWN | Class 1 | General, Plastic Surgery | No | 2019-09-20 |
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