Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3036718423

FEI Number

3036718423

Entity Name

AMES MEDICAL PROSTHETIC SOLUTIONS, S.A.U.

City/State/Country

St. Feliu del Llobregat Barcelona, ES

Establishment Address

Ctra. Laurea Miro, 388, St. Feliu del Llobregat Barcelona 08980, ES

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

AMES MEDICAL Prosthetic Solutions, S.A.U. (Owner Number: 10092888)

Owner / Operator Contact Address

Ctra. Laurea Miro, 388, St. Feliu del Llobregat, ES-B 08980, ES

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K240461

PMA Number

N/A

All Registered Proprietary Names

OsteoSinter® EVANS and COTTON wedges and related accessories

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PLF	Bone Wedge	Orthopedic	Class 2	888.3030	2025-03-03

Official Correspondent

Emili Tarrats

US Agent Details

Wen Wang Email: Wen.Wang@WillowGlenFDA.com Phone: (619) 8690249

Related Public Records

Same Entity

AMES MEDICAL Prosthetic Solutions, S.A.U.

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
K252254	Sinaptic Surgical	Osteotomy Wedge System	2025-10-17

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3014004349	Arthrex Singapore Pte Ltd.	Singapore Central Singapore, SG

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3036718423. Last updated year: 2026. Please use registration number 3036718423 when referencing this establishment in official correspondence.