Data / Medical devices / Brazil / Neoortho Produtos Ortopedicos S/A

Neoortho Produtos Ortopedicos S/A: FDA-registered device maker in Curitiba Parana, Brazil, 6 510(k) clearances

Name: Neoortho Produtos Ortopedicos S/A FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Neoortho Produtos Ortopedicos S/A is registered with the FDA (registration 3009158523) in Curitiba Parana, Brazil. It lists 28 device types. The FDA files 6 510(k) clearances under its listings, the newest dated December 6, 2022. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Neoortho Produtos Ortopedicos S/A

FDA registration number: 3009158523
Address: Rua Angelo Domingos Durigan, 607 Cascatinha, Curitiba Parana, Brazil, 82025-100
Owner or operator: NEOORTHO Produtos Ortopedicos S/A (10036684)
Roles: Contract manufacturer, Manufacturer
First device listed: May 19, 2011
Registered through: 2026
Brand names listed: Cannulated Screws Neoortho, CranioMaxillofacial Fixation (CMF) System - CMF Visionare, Femoral Trochanteric Nail System - Neonail, Intramedullary Nail and Screws - NEONAIL, Mini and Micro Fragments Reconstruction System - NEOFACE, Mini and Micro Fragments Reconstruction System-Neofix, Neoortho, Small and Large Fragments Osteosynthesis System NEOFIX and more

Devices it lists

Device	Product code	Class	Role	Source
Bit, Drill	HTW	1	Manufacturer	accessdata.fda.gov
Bur, Surgical, General & Plastic Surgery	GFF	1	Manufacturer	accessdata.fda.gov
Clamp	HXD	1	Manufacturer	accessdata.fda.gov
Forceps, General & Plastic Surgery	GEN	1	Manufacturer	accessdata.fda.gov
Gauge, Depth	HTJ	1	Manufacturer	accessdata.fda.gov
Guide, Surgical, Instrument	FZX	1	Manufacturer	accessdata.fda.gov
Impactor	HWA	1	Manufacturer	accessdata.fda.gov
Instrument, Bending Or Contouring	HXP	1	Manufacturer	accessdata.fda.gov
Instrument, Compression	HWN	1	Manufacturer	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Manufacturer	accessdata.fda.gov
Plastic Surgery And Accessories Kit	FTN	1	Manufacturer	accessdata.fda.gov
Plate, Bone	JEY	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Plate, Fixation, Bone	HRS	2	Manufacturer	accessdata.fda.gov
Pliers, Surgical	HTC	1	Manufacturer	accessdata.fda.gov
Probe	HXB	1	Manufacturer	accessdata.fda.gov
Reamer	HTO	1	Manufacturer	accessdata.fda.gov
Retractor	GAD	1	Manufacturer	accessdata.fda.gov
Rod, Fixation, Intramedullary And Accessories	HSB	2	Manufacturer	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Manufacturer	accessdata.fda.gov
Screw, Fixation, Intraosseous	DZL	2	Contract manufacturer	accessdata.fda.gov
Screwdriver	HXX	1	Manufacturer	accessdata.fda.gov
Template	HWT	1	Manufacturer	accessdata.fda.gov
Tray, Surgical	LRP	1	Manufacturer	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Manufacturer	accessdata.fda.gov
Trocar, Ent	KTE	1	Manufacturer	accessdata.fda.gov
Washer, Bolt Nut	HTN	2	Manufacturer	accessdata.fda.gov
Wrench	HXC	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 6, 2022	K221021	Femoral Trochanteric Nail System Neonail	HSB	Substantially Equivalent	Neoortho Produtos Ortopédicos S/A	accessdata.fda.gov
June 27, 2017	K162874	Cannulated Screws Neoortho	HWC	Substantially Equivalent	Neoortho Produtos Ortopedicos S/A	accessdata.fda.gov
December 16, 2014	K142419	Mini and Micro Fragments Reconstruction System-NEOFIX	HRS	Substantially Equivalent	Neoortho Productos Orthopedicos S/A	accessdata.fda.gov
September 23, 2014	K141103	INTRAMEDULLARY NAIL AND SCREWS-NEONAIL	HSB	Substantially Equivalent	Neoortho Produtos Ortopedicos S/A	accessdata.fda.gov
March 23, 2012	K113733	SMALL AND LARGE FRAGMENTS OSTEOSYNTHESIS SYSTEM NEOFIX	HRS	Substantially Equivalent	Neoortho Produtos Ortopedicos S/A	accessdata.fda.gov
December 20, 2010	K102641	MINI AND MICRO FRAGMENTS RECONSTRUCTION SYSTEM-NEOFACE	JEY	Substantially Equivalent	Neoortho Produtos Ortopedicos S/A	accessdata.fda.gov

Compare with other makers

Updated December 6, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.