PRECIMADE

FDA Device Registration & Listing · Bourg en Bresse Ain, FR · Registration 3011943495

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
3011943495
FEI Number
3011943495
Entity Name
PRECIMADE
City/State/Country
Bourg en Bresse Ain, FR
Establishment Address
20 av Arsene d'Arsonval, Bourg en Bresse Ain 01000, FR
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Precimade (Owner Number: 10054968)
Owner / Operator Contact Address
161 Avenue Franklin Roosevelt, Decines, FR-ARA 69150, FR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

FX V135 Shoulder Prosthesis

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2022-12-07
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2022-12-07
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2022-12-07
GFG Bit, Surgical General, Plastic Surgery Class 1 878.4820 2025-04-23
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2022-12-07
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2022-12-07
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2022-12-07
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2022-12-07
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2022-12-07
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2022-12-07
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2017-05-21
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2017-05-21
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2017-05-21

Official Correspondent

Marc GAGNANT

US Agent Details

Brian Rogers Email: brogers@fxshouldersolutions.com Phone: (339) 2371462

Related Public Records

Same Entity

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

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K984202 Howmedica, Inc. HOWMEDICA HUMERAL INTERCALARY SYSTEM 1999-02-05
K141345 Tornier S.A.S. AEQUALIS FX2 2014-11-18

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0012-2019 Exactech, Inc. 2
Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011943495. Last updated year: 2026. Please use registration number 3011943495 when referencing this establishment in official correspondence.
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