EPISURF OPERATIONS AB

FDA Device Registration & Listing · Stockholm, SE · Registration 3015341893

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
3015341893
FEI Number
3015341893
Entity Name
EPISURF OPERATIONS AB
City/State/Country
Stockholm, SE
Establishment Address
Karlavagen 60, Stockholm 11449, SE
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
Episurf Operations AB (Owner Number: 10087531)
Owner / Operator Contact Address
Karlavagen 60, Stockholm, SE-AB 11449, SE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K221048
PMA Number
N/A

All Registered Proprietary Names

EpisurfView Femoral Epidummy Patellar Epidummy Episealer® Patellofemoral System Patellar Adjustment Socket Femoral Adjustment Socket Femoral Drilling Socket Patellar Epiguide Patellar Component Femoral Epidrill Femoral Epiguide Femoral Component Femoral Epimandrel Patellar Epimandrel Patellar Epidrill

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LMD System, Digital Image Communications, Radiological Radiology Class 1 892.2020 2026-03-10
KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3540 2023-03-11

Official Correspondent

Ylva Bonde

US Agent Details

Patrick Jamnik Email: patrick.jamnik@episurf.com Phone: (214) 9836156

Related Public Records

Same Entity

Episurf Operations AB
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015341893. Last updated year: 2026. Please use registration number 3015341893 when referencing this establishment in official correspondence.
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