Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009685086

FEI Number

3009685086

Entity Name

BIOMECANICA INDUSTRIA E COMERCIO DE PRODUTOS ORTOPEDICOS LTDA

City/State/Country

Jau Sao Paulo, BR

Establishment Address

Rua Luiz Pengo 145, Jau Sao Paulo 17212811, BR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Biomecanica Industria e Comercio de Produtos Ortopedicos Ltd (Owner Number: 10093117)

Owner / Operator Contact Address

Rua Luiz Pengo 145, Jau, BR-SP 17212811, BR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K212729

PMA Number

N/A

All Registered Proprietary Names

Bone Cement - Normal Viscosity

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2025-04-01

Official Correspondent

Melina Roncada

US Agent Details

PASSARINI CRO AND REGULATORY SOLUTIONS LLC Email: usagent@passarini.com.br Phone: (786) 8496760

Related Public Records

Same Entity

Biomecanica Industria e Comercio de Produtos Ortopedicos Ltd

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 3009685086. Last updated year: 2026. Please use registration number 3009685086 when referencing this establishment in official correspondence.