Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027556146

FEI Number

3027556146

Entity Name

PROTOTAL UK

City/State/Country

Thatcham West Berkshire, GB

Establishment Address

Unit 14-15, Fulton Court, Greenham Business Park, Thatcham West Berkshire RG196HD, GB

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Prototal UK (Owner Number: 10088307)

Owner / Operator Contact Address

Unit 14-15, Fulton Court, Greenham Business Park, Thatcham, GB-WBK RG196HD, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Patellar Epimandrel Femoral Epimandrel Patellar Epidummy Episealer Knee Revision Guide Femoral Epidummy Patellar Epiguide Femoral Epiguide

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KRR	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3540	2023-06-27

Official Correspondent

Paul Dicker

US Agent Details

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

Related Public Records

Same Entity

Prototal UK

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 3027556146. Last updated year: 2026. Please use registration number 3027556146 when referencing this establishment in official correspondence.