Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043620689

FEI Number

3043620689

Entity Name

ORTOFACE COSMETICOS E PRODUTOS PARA SAUDE LTDA

City/State/Country

Salto Sao Paulo, BR

Establishment Address

Rua Rodrigues Alves, 505, Centro, Salto Sao Paulo 13320130, BR

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

GM dos Reis Industria e Comercio Ltda (Owner Number: 10059832)

Owner / Operator Contact Address

Avenida Pierre Simon de La Place, 600, Campinas, BR-SP 13069320, BR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K260390

PMA Number

N/A

All Registered Proprietary Names

Orthopedic manual surgical instruments Percutaneous Foot Burrs, GMREIS Arthodesis Burrs, GMREIS STA - ACHILLES TENDON SUTURE SYSTEM 312-500 - MULTICUTTER - Arthroscopic Retrograde Drill 359-210 - ACCESS FIT RIGHT SUTURE PASSER 335-200 - MICRO EASYPASS - SMALL CURVED MICRO SUTURE PASSER 335-100 - MICRO EASYPASS - STRAIGHT MICRO SUTURE PASSER 335-99 - MICRO EASYPASS - SHORT CURVED MICRO SUTURE PASS 335-300 - MICRO EASYPASS - LARGE CURVED MICRO SUTURE PASSER 359-200 - ACCESS FIT STRAIGHT SUTURE PASSER 359-220 - ACCESS FIT LEFT SUTURE PASSER 335-600 - MICRO EASYPASS - EXTRA LARGE CURVED MICRO SUTURE PASSER TEMPLATE Tray, Surgical, Instrument Screw Removal Kit Meniscus Versaflex

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2023-06-15
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2025-06-13
JDQ	Cerclage, Fixation	Orthopedic	Class 2	888.3010	2025-08-21
HTT	Burr, Orthopedic	Orthopedic	Class 1	888.4540	2022-08-30
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-08
JDP	Condylar Plate Fixation Implant	Orthopedic	Class 2	888.3030	2021-04-08
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-08
JDQ	Cerclage, Fixation	Orthopedic	Class 2	888.3010	2021-04-08
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2022-09-06
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2023-04-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-06-28
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-06-28
HWT	Template	Orthopedic	Class 1	888.4800	2019-05-31
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2019-02-27
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-01-02
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-01-02
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2019-05-31
HWB	Extractor	Orthopedic	Class 1	888.4540	2026-02-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-11-26
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-11-26
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2024-11-04
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-11-26
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-11-26
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2026-02-27
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-01-18
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-01-18
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-08-07
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2026-03-30
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2026-03-30

Official Correspondent

Paula Oliveira

US Agent Details

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

Related Public Records

Same Entity

GM dos Reis Industria e Comercio Ltda

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3013756169	GM DOS REIS INDUSTRIA E COMERCIO LTDA	Campinas Sao Paulo, BR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K040336	Synthes (Usa)	SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM	2004-04-12
K083648	Efratgo, Ltd. HI Tech Bio-Surgical	GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL	2009-05-14
K192312	Zimmer GmbH	Zimmer Natural Nail System Cephalomedullary Nails	2019-10-11
K002057	Biomet Orthopedics, Inc.	BROOKER TIBIA NAILS	2000-10-04
K874919	Orthomet, Inc.	ORTHOMET WIRE FOR SUTURE, CERCLAGE	1988-01-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043620689. Last updated year: 2026. Please use registration number 3043620689 when referencing this establishment in official correspondence.