Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021907852

FEI Number

3021907852

Entity Name

RAZEK EQUIPAMENTOS LTDA

City/State/Country

Sao Carlos Sao Paulo, BR

Establishment Address

Al. Sinlioku Tanaka, 170, Pq Ecotec Damha, Sao Carlos Sao Paulo 13565-261, BR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

RAZEK EQUIPAMENTOS LTDA (Owner Number: 10084627)

Owner / Operator Contact Address

Al. Sinlioku Tanaka, 170, Pq Ecotec Damha, Sao Carlos, BR-SP 13565-261, BR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Razek Arthroscopy Cannulas Razek Arthroscopy Instruments RZ Tunneling Drill DBI Razek Cannula Osteomax Cannula Kit for Bone Debridement Razek Microdebridement Cannula Aggressive Cannula for Bone Impact Mini Microdebridement Cannula - ENTP Mini Microdebridement Cannula - ENT Mini Microdebridement Cannula - ENTM Razek Hip Microdebridement Cannula Mini Microdebridement Cannula Razek Surgical Burrs Razek PLM Instruments Razek NiSL Instruments Razek Diamond Burrs Razek MTCN Instruments Razek Burrs for Foot Surgery Razek NiCN Instruments Razek MTSL Instruments Razek Suture Passer Hook

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2022-03-14
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2022-03-15
GEY	Motor, Surgical Instrument, Ac-Powered	General, Plastic Surgery	Class 1	878.4820	2024-06-19
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2022-03-15

Official Correspondent

No official correspondent registered.

US Agent Details

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

Related Public Records

Same Entity

RAZEK EQUIPAMENTOS LTDA

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
K905383	Micro Surgical Instruments Corp.	2710-000 OSCILLATING SAW, GENERAL ASSEMBLY	1991-06-18
K913369	Micro Surgical Instruments Corp.	MICRO-AIRE MODEL 2060	1991-11-01

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0040-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 3mm Offset (Blue) Catalog Number: 72201713 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0041-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 4mm Offset (Purple Catalog Number: 72201714 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0042-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 5mm Offset (Red) Catalog Number: 72201715 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0043-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 6mm Offset (Green) Catalog Number: 72201716 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0044-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 7mm Offset (Gold) Catalog Number: 72201717 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.

Similar Registrations

Registration Number	Establishment Name	Location
3017450165	NANICE MEDICAL SOLUTIONS, LLC	Flourtown, PA, US
1526711	ISOMEDIX OPERATIONS INC	GROVEPORT, OH, US
2647346	MEDTRONIC PUERTO RICO OPERATIONS CO., HUMACAO	HUMACAO, PR, US
3010011359	BIORAD MEDISYS PVT. LTD.	Pune Maharashtra, IN
9611278	Stengelin Medical GmbH	TUTTLINGEN Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021907852. Last updated year: 2026. Please use registration number 3021907852 when referencing this establishment in official correspondence.