Data / Medical devices / Germany / Joimax GMBH
Joimax GMBH: FDA-registered device maker in KARLSRUHE Baden-Wurttemberg, Germany, 10 510(k) clearances
Joimax GMBH is registered with the FDA (registration 3005083075) in KARLSRUHE Baden-Wurttemberg, Germany. It lists 44 device types. The FDA files 10 510(k) clearances under its listings, the newest dated September 1, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005083075
- Address
- AMALIENBADSTRASSE 41 Raumfabrik 61, KARLSRUHE Baden-Wurttemberg, Germany, 76227
- Owner or operator
- Joimax GmbH (9070895)
- Roles
- Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- March 25, 2005
- Registered through
- 2026
- Brand names listed
- Camsource, DUO, Elevator, EndoLIF, EndoLIF(R) Delta-Cage, EndoLIF(R) DoubleWedge-Cage, EndoLIF®, Endovapor®2 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|
| Accessories, Arthroscopic | NBH | 1 | Manufacturer | accessdata.fda.gov |
| Accessories, Cleaning Brushes, For Endoscope | MNL | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Adaptor, Bulbs, Miscellaneous, For Endoscope | FFY | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Arthroscope | HRX | 2 | Manufacturer | accessdata.fda.gov |
| Awl | HWJ | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Camera, Surgical And Accessories | KQM | 1 | Manufacturer | accessdata.fda.gov |
| Camera, Television, Endoscopic, Without Audio | FWF | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Cart, Emergency, Cardiopulmonary (Excluding Equipment) | BZN | 1 | Foreign private label distributor | accessdata.fda.gov |
| Cement, Bone, Vertebroplasty | NDN | 2 | Exporter to the US | accessdata.fda.gov |
| Curette, Surgical, General Use | FZS | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Cutter, Wire | HXZ | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Device, Digital Image Storage, Radiological | LMB | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Dispenser, Liquid Medication | KYX | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 2 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Elevator, Surgical, General & Plastic Surgery | GEG | 1 | Manufacturer | accessdata.fda.gov |
| Forceps, General & Plastic Surgery | GEN | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Guide, Needle, Surgical | GDF | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Hammer, Surgical | FZY | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Holder, Needle; Orthopedic | HXK | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Instrument, Surgical, Non-Powered | HAO | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Kit, Surgical Instrument, Disposable | KDD | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Lavage, Jet | FQH | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Marker, Skin | FZZ | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Needle, Aspiration And Injection, Disposable | GAA | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Orthopedic Stereotaxic Instrument | OLO | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Orthosis, Spinal Pedicle Fixation | MNI | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Osteotome, Manual | GFI | 1 | Manufacturer | accessdata.fda.gov |
| Passer, Wire, Orthopedic | HXI | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Punch, Surgical | LRY | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Rasp, Surgical, General & Plastic Surgery | GAC | 1 | Manufacturer | accessdata.fda.gov |
| Reamer | HTO | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Scissors, Orthopedic, Surgical | HRR | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Table And Attachments, Operating-Room | BWN | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Table, Operating-Room, Electrical | GDC | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Tape, Measuring, Rulers And Calipers | FTY | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Thoracolumbosacral Pedicle Screw System | NKB | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Exporter to the US, Manufacturer | 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 |
|---|
| September 1, 2021 | K203014 | EndoLIF Delta-Cage and DoubleWedge-Cage | MAX | Substantially Equivalent | Joimax GmbH | accessdata.fda.gov |
| July 30, 2020 | K192663 | Joimax Intracs System | OLO | Substantially Equivalent | Joimax GmbH | accessdata.fda.gov |
| December 18, 2019 | K192680 | Percusys® Plus Pedicle Screw System | NKB | Substantially Equivalent | Joimax GmbH | accessdata.fda.gov |
| April 21, 2017 | K170358 | joimax Endovapor 2 | GEI | Substantially Equivalent | Joimax GmbH | accessdata.fda.gov |
| November 2, 2016 | K161378 | joimax Electrosurgical Instruments | GEI | Substantially Equivalent | Joimax GmbH | accessdata.fda.gov |
| July 9, 2015 | K151143 | EndoLIF On-Cage | MAX | Substantially Equivalent | Joimax GmbH | accessdata.fda.gov |
| February 3, 2015 | K143200 | MIS Z-Pedicle Screw System | NKB | Substantially Equivalent | Z-Medical GmbH & Co. KG | accessdata.fda.gov |
| July 5, 2013 | K123234 | ERMIS STERILIZATION CONTAINER SYSTEM | KCT | Substantially Equivalent | Ermis Medizintechnik | accessdata.fda.gov |
| August 12, 2005 | K051827 | JOIMAX ENDOSCOPE/MULTISCOPE, THESSYS FORAMINOSCOPE/MULTISCOPE, THESSYS LAMINOSCOPE/MULTISCOPE | HRX | Substantially Equivalent | Joimax GmbH | accessdata.fda.gov |
| June 9, 2005 | K042415 | MENDEC SPINE | NDN | Substantially Equivalent | Tecres S.P.A. | accessdata.fda.gov |
Compare with other makers
- All makers of Instrument, Surgical, Non-Powered
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- All makers of Guide, Surgical, Instrument
- All makers of Adaptor, Bulbs, Miscellaneous, For Endoscope
- All makers of Forceps, General & Plastic Surgery
Updated September 1, 2021. 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.