Innomedic GmbH

FDA Device Registration & Listing · Phillipsburg-Rheinsheim Baden-Wurttemberg, DE · Registration 3013510178

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013510178
FEI Number
3013510178
Entity Name
Innomedic GmbH
City/State/Country
Phillipsburg-Rheinsheim Baden-Wurttemberg, DE
Establishment Address
Forstdeichstr, 1-3 76661, Phillipsburg-Rheinsheim Baden-Wurttemberg 76661, DE
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
SYNTHES GMBH / Synthes Produktions GmbH (Owner Number: 9071542)
Owner / Operator Contact Address
1301 Goshen Parkway, West Chester, PA 19380, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K161417
PMA Number
N/A

All Registered Proprietary Names

DePuy Synthes MAXFRAME Multi-Axial Correction System MAXFRAME Multi-Axial Correction System (Aka MAXFRAME) MAXFRAME Autostrut DePuy Synthes MAXFRAME Multi-Axial Correction System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2021-06-30
OSN Software For Diagnosis/Treatment Orthopedic Class 2 888.3030 2021-06-30
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2023-09-11
OSN Software For Diagnosis/Treatment Orthopedic Class 2 888.3030 2023-09-11
OSN Software For Diagnosis/Treatment Orthopedic Class 2 888.3030 2017-01-25
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2017-01-25

Official Correspondent

No official correspondent registered.

US Agent Details

KAREN PARKER Email: kparker2@its.jnj.com Phone: (610) 7196567

Related Public Records

Same Entity

SYNTHES GMBH / Synthes Produktions GmbH
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
8030965 SYNTHES GMBH / Synthes Produktions GmbH Oberdorf, Baselland Basel-Landschaft, CH
3000270450 Synthes GMBH Selzach Solothurn, CH
3009417901 SYNTHES GMBH Zuchwil Solothurn, CH

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K033476 Howmedica Osteonics Corp. MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM 2004-01-20

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013510178. Last updated year: 2026. Please use registration number 3013510178 when referencing this establishment in official correspondence.
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