Data / Medical devices / Germany / Innomedic GmbH
Innomedic GmbH: FDA-registered device maker in Phillipsburg-Rheinsheim Baden-Wurttemberg, Germany, 4 510(k) clearances
Innomedic GmbH is registered with the FDA (registration 3013510178) in Phillipsburg-Rheinsheim Baden-Wurttemberg, Germany. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated June 11, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3013510178
- Address
- Forstdeichstr, 1-3 76661, Phillipsburg-Rheinsheim Baden-Wurttemberg, Germany, 76661
- Owner or operator
- SYNTHES GMBH / Synthes Produktions GmbH (9071542)
- Roles
- Specification developer
- First device listed
- January 25, 2017
- Registered through
- 2027
- Brand names listed
- DePuy Synthes MAXFRAME Multi-Axial Correction System, MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System, MAXFRAME Autostrut, MAXFRAME Multi-Axial Correction System (Aka MAXFRAME)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | 2 | Specification developer | accessdata.fda.gov |
| Software For Diagnosis/Treatment | OSN | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| June 11, 2026 | K254087 | MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System | KTT | Substantially Equivalent | Synthes (USA) Products, LLC | accessdata.fda.gov |
| May 25, 2021 | K211313 | MAXFRAME Multi-Axial Correction System (aka MAXFRAME) | KTT | Substantially Equivalent | Synthes (USA) Products, LLC | accessdata.fda.gov |
| January 6, 2021 | K202810 | AutoStrut G2 | KTT | Substantially Equivalent | Orthospin, Ltd. | accessdata.fda.gov |
| November 10, 2016 | K161417 | DePuy Synthes MAXFRAME Multi-Axial Correction System | KTT | Substantially Equivalent | Synthes USA, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- All makers of Software For Diagnosis/Treatment
Updated June 11, 2026. 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.