Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009158523

FEI Number

3009158523

Entity Name

NEOORTHO PRODUTOS ORTOPEDICOS S/A

City/State/Country

Curitiba Parana, BR

Establishment Address

Rua Angelo Domingos Durigan, 607, Cascatinha, Curitiba Parana 82025-100, BR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

NEOORTHO Produtos Ortopedicos S/A (Owner Number: 10036684)

Owner / Operator Contact Address

Rua Angelo Domingos Durigan, 607, Cascatinha, Curitiba, BR-PR 82025-100, BR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Neoortho Neoortho Neoortho Neoortho Neoortho Neoortho Neoortho Neoortho Neoortho Neoortho Neoortho Mini and Micro Fragments Reconstruction System - NEOFACE Neoortho Neoortho Neoortho Femoral Trochanteric Nail System - Neonail Neoortho Neoortho Neoortho Mini and Micro Fragments Reconstruction System-Neofix Neoortho Neoortho

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HWN	Instrument, Compression	Orthopedic	Class 1	888.4540	2014-08-26
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	2011-05-19
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2011-05-19
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2011-05-19
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2011-05-19
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2011-05-19
HXC	Wrench	Orthopedic	Class 1	888.4540	2014-08-26
HWT	Template	Orthopedic	Class 1	888.4800	2011-05-19
HWA	Impactor	Orthopedic	Class 1	888.4540	2014-08-26
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2011-05-19
HTO	Reamer	Orthopedic	Class 1	888.4540	2014-12-08
JEY	Plate, Bone	Dental	Class 2	872.4760	2011-05-19
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2014-08-26
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2011-05-19
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2023-11-13
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2014-08-26
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2014-12-08
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2014-12-17
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2014-12-17
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2011-05-19

Official Correspondent

Elaine Patricia Thome Rossetto

US Agent Details

Marina Adami Business: Visionare LLC Email: regulatoryaffairs@visionare.us Phone: (239) 4065674

Related Public Records

Same Entity

NEOORTHO Produtos Ortopedicos S/A

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
K851170	The Huxley Instrument Corp.	DISSECTING TWEEZER #283-72PCS. SS 410	1985-04-25
K821248	Conphar, Inc.	ROCHESTER PEAN FORCEPS	1982-05-28
K881095	CooperVision, Inc.	KOI(TM) INSTRUMENT TRAYS	1988-04-06
K172572	Stryker	Stryker Upper-Face AXS screws and Mid-Face AXS screws	2017-10-31
K121589	Biomet Microfixation	BIOMET MICROFIXATION FACIAL PLATING SYSTEM	2012-09-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0036-2010	Alphatec Spine, Inc.	1	ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.
Z-0010-2008	N/A	1	EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.
Z-0021-2015	Biomet, Inc.	1	Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.
Z-0043-2007	Bioplate Inc	2	Bioplate Resorbable Bone Fixation Tack, Catalog Number: 89-0120, Item Number: SG#-45

Similar Registrations

Registration Number	Establishment Name	Location
1064129	Orthopedic Designs North America, Inc.	Tampa, FL, US
3006639944	SHANDONG WEIGAO ORTHOPAEDIC DEVICE CO.,LTD	weihai Shandong, CN
3009554293	CG MedTech USA, Inc.	Irvine, CA, US
3008812560	Synthes (USA) Products LLC	West Chester, PA, US
3007143290	NEWCLIP TECHNICS SAS	HAUTE GOULAINE Loire-Atlantique, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009158523. Last updated year: 2026. Please use registration number 3009158523 when referencing this establishment in official correspondence.