Joimax GmbH
Irvine, CA, US
JOIMAX GMBH appears in FDA device records in Irvine, CA. FDA records list 7 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Joimax GmbH between 2005 and 2021. The busiest year on record is 2005, with 1. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K203014 | EndoLIF Delta-Cage and DoubleWedge-Cage | MAX | Substantially Equivalent | |
| K192663 | Joimax Intracs System | OLO | Substantially Equivalent | |
| K192680 | Percusys® Plus Pedicle Screw System | NKB | Substantially Equivalent | |
| K170358 | joimax Endovapor 2 | GEI | Substantially Equivalent | |
| K161378 | joimax Electrosurgical Instruments | GEI | Substantially Equivalent | |
| K151143 | EndoLIF On-Cage | MAX | Substantially Equivalent | |
| K051827 | JOIMAX ENDOSCOPE/MULTISCOPE, THESSYS FORAMINOSCOPE/MULTISCOPE, THESSYS LAMINOSCOPE/MULTISCOPE | HRX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005083075 | 3005083075 | JOIMAX GMBH | AMALIENBADSTRASSE 41, KARLSRUHE Baden-Wurttemberg 76227 DE | 2026 | and 34 more, listed in full below |
| 3005042595 | 3005042595 | JOIMAX, INC. | 140 Technology Drive, Suite 150, Irvine, CA 92618 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NBHAccessories, Arthroscopic
- MNLAccessories, Cleaning Brushes, For Endoscope
- FFYAdaptor, Bulbs, Miscellaneous, For Endoscope
- HRXArthroscope
- HWJAwl
- KQMCamera, Surgical And Accessories
- FWFCamera, Television, Endoscopic, Without Audio
- BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)
- NDNCement, Bone, Vertebroplasty
- FZSCurette, Surgical, General Use
- HXZCutter, Wire
- LMBDevice, Digital Image Storage, Radiological
- KYXDispenser, Liquid Medication
- PUIDrape, Surgical, Exempt
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- GEGElevator, Surgical, General & Plastic Surgery
- GENForceps, General & Plastic Surgery
- GDFGuide, Needle, Surgical
- FZXGuide, Surgical, Instrument
- FZYHammer, Surgical
- HXKHolder, Needle; Orthopedic
- HAOInstrument, Surgical, Non-Powered
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- KDDKit, Surgical Instrument, Disposable
- FQHLavage, Jet
- FZZMarker, Skin
- GAANeedle, Aspiration And Injection, Disposable
- LXHOrthopedic Manual Surgical Instrument
- OLOOrthopedic Stereotaxic Instrument
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- GFIOsteotome, Manual
- HXIPasser, Wire, Orthopedic
- LRYPunch, Surgical
- GACRasp, Surgical, General & Plastic Surgery
- HTOReamer
- HRRScissors, Orthopedic, Surgical
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
- BWNTable And Attachments, Operating-Room
- GDCTable, Operating-Room, Electrical
- FTYTape, Measuring, Rulers And Calipers
- NKBThoracolumbosacral Pedicle Screw System
- FSMTray, Surgical, Instrument
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain