Data / Medical devices / Germany / HG Medical GmbH
HG Medical GmbH: FDA-registered device maker in Raisting Bavaria, Germany, 1 510(k) clearance
HG Medical GmbH is registered with the FDA (registration 3006272282) in Raisting Bavaria, Germany. It lists 31 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 3, 2013. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3006272282
- Address
- Gewerbegebiet 16, Raisting Bavaria, Germany, 82399
- Owner or operator
- hg medical GmbH (10023065)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- November 1, 2007
- Registered through
- 2026
- Brand names listed
- 3Di Plates, ALPHALOK Plating System, AO Quick Connect, APS Plates, Alpha Lock System, Anatomical Staple, Ankle Fusion, Anterior Staple Drills and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|
| Anterior Staple As Supplemental Fixation For Fusion | PHQ | 2 | Contract manufacturer | accessdata.fda.gov |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | 2 | Contract manufacturer | accessdata.fda.gov |
| Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | KTW | 2 | Contract manufacturer | accessdata.fda.gov |
| Appliance, Fixation, Spinal Interlaminal | KWP | 2 | Contract manufacturer | accessdata.fda.gov |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | 2 | Contract manufacturer | accessdata.fda.gov |
| Bit, Surgical | GFG | 1 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Countersink | HWW | 1 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Cutter, Wire | HXZ | 1 | Contract manufacturer | accessdata.fda.gov |
| Driver, Prosthesis | HWR | 1 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | 2 | Contract manufacturer | accessdata.fda.gov |
| Forceps | HTD | 1 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Gauge, Depth | HTJ | 1 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | 1 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | 2 | Contract manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Orthosis, Spinal Pedicle Fixation | MNI | 2 | Contract manufacturer | accessdata.fda.gov |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | 2 | Contract manufacturer | accessdata.fda.gov |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | 2 | Contract manufacturer | accessdata.fda.gov |
| Pin, Fixation, Smooth | HTY | 2 | Contract manufacturer | accessdata.fda.gov |
| Plate, Fixation, Bone | HRS | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | HSN | 2 | Contract manufacturer | accessdata.fda.gov |
| Rod, Fixation, Intramedullary And Accessories | HSB | 2 | Contract manufacturer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Contract manufacturer | accessdata.fda.gov |
| Shoulder Prosthesis, Reverse Configuration | PHX | 2 | Contract manufacturer | accessdata.fda.gov |
| Staple, Fixation, Bone | JDR | 2 | Contract manufacturer | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | 2 | Contract manufacturer | accessdata.fda.gov |
| Tray, Surgical | LRP | 1 | Exporter to the US | accessdata.fda.gov |
| Washer, Bolt Nut | HTN | 2 | Contract 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 |
|---|
| July 3, 2013 | K131474 | ARTHREX DISTAL RADIUS PLATE SYSTEM | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Guide, Surgical, Instrument
- All makers of Screw, Fixation, Bone
- All makers of Plate, Fixation, Bone
- All makers of Fastener, Fixation, Nondegradable, Soft Tissue
- All makers of Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- All makers of Washer, Bolt Nut
Updated July 3, 2013. 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.