Data / Medical devices / Brazil / GM Dos Reis Industria E Comercio Ltda

GM Dos Reis Industria E Comercio Ltda: FDA-registered device maker in Campinas Sao Paulo, Brazil, 21 510(k) clearances

Name: GM Dos Reis Industria E Comercio Ltda FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

GM Dos Reis Industria E Comercio Ltda is registered with the FDA (registration 3013756169) in Campinas Sao Paulo, Brazil. It lists 21 device types. The FDA files 21 510(k) clearances under its listings, the newest dated August 22, 2026. Registered through 2027. 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 GM Dos Reis Industria E Comercio Ltda

FDA registration number: 3013756169
Address: Avenida Pierre Simon de La Place, 600, Campinas Sao Paulo, Brazil, 13069320
Owner or operator: GM dos Reis Industria e Comercio Ltda (10059832)
Roles: Manufacturer, Repackager or relabeler
First device listed: February 27, 2019
Registered through: 2027
Brand names listed: 312-500 - MULTICUTTER - Arthroscopic Retrograde Drill, 335-100 - MICRO EASYPASS - STRAIGHT MICRO SUTURE PASSER, 335-200 - MICRO EASYPASS - SMALL CURVED MICRO SUTURE PASSER, 335-300 - MICRO EASYPASS - LARGE CURVED MICRO SUTURE PASSER, 335-600 - MICRO EASYPASS - EXTRA LARGE CURVED MICRO SUTURE PASSER, 335-99 - MICRO EASYPASS - SHORT CURVED MICRO SUTURE PASS, 354-100-050 - Meniscus Suture - OUT IN, 359-200 - ACCESS FIT STRAIGHT SUTURE PASSER and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Arthroscopic	NBH	1	Manufacturer	accessdata.fda.gov
Burr, Orthopedic	HTT	1	Manufacturer	accessdata.fda.gov
Cerclage, Fixation	JDQ	2	Manufacturer	accessdata.fda.gov
Condylar Plate Fixation Implant	JDP	2	Manufacturer	accessdata.fda.gov
Extractor	HWB	1	Manufacturer	accessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft Tissue	MBI	2	Manufacturer	accessdata.fda.gov
Instrument, Ligature Passing And Knot Tying	HCF	1	Manufacturer	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Manufacturer	accessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	HWE	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment	KIJ	1	Manufacturer	accessdata.fda.gov
Kit, Surgical Instrument, Disposable	KDD	1	Manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Manufacturer	accessdata.fda.gov
Passer	HWQ	1	Manufacturer	accessdata.fda.gov
Plate, Fixation, Bone	HRS	2	Manufacturer	accessdata.fda.gov
Rod, Fixation, Intramedullary And Accessories	HSB	2	Manufacturer	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polyethylene	GAT	2	Manufacturer	accessdata.fda.gov
Template	HWT	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Thoracolumbosacral Pedicle Screw System	NKB	2	Manufacturer	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Washer, Bolt Nut	HTN	2	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
August 22, 2026	K253910	Stitch - Suture Wires and Tapes	GAT	Substantially Equivalent	GM Dos Reis Industria e Comercio Ltda.	accessdata.fda.gov
August 19, 2026	K262537	Versalock Sterile Plating System	HRS	Substantially Equivalent	GM Dos Reis Industria e Comercio Ltda.	accessdata.fda.gov
July 21, 2026	K261406	Versalock Proximal Tibial Plating System	HRS	Substantially Equivalent	GM Dos Reis Industria e Comercio Ltda.	accessdata.fda.gov
March 17, 2026	K260390	Super Upper Limbs Versalock Plating System	HRS	Substantially Equivalent	GM Dos Reis Industria e Comercio Ltda.	accessdata.fda.gov
February 19, 2026	K254188	Meniscus Versaflex	GAT	Substantially Equivalent	GM Dos Reis Industria e Comercio Ltda.	accessdata.fda.gov
December 19, 2025	K251050	Pectus Versa System	HRS	Substantially Equivalent	Gm Dos Reis Industria E Comercio	accessdata.fda.gov
November 4, 2025	K252664	GMReis Suture Anchors	MBI	Substantially Equivalent	GM Dos Reis Industria e Comercio Ltda.	accessdata.fda.gov
August 14, 2025	K243905	Stitch Cerclage Suture Tapes	JDQ	Substantially Equivalent	GM Dos Reis Industria e Comercio Ltda.	accessdata.fda.gov
June 12, 2025	K250559	GMReis Fibula Nail System	HSB	Substantially Equivalent	Gm Dos Reis Industria E Comercio	accessdata.fda.gov
January 29, 2025	K243740	Versalock Upper Limb Plating System	HRS	Substantially Equivalent	GM Dos Reis Industria e Comercio Ltda.	accessdata.fda.gov
November 21, 2024	K242998	GMReis Ankle Plating System	HRS	Substantially Equivalent	GM Dos Reis Industria e Comercio Ltda.	accessdata.fda.gov
November 21, 2024	K242596	Versalock Mini and Micro Plating System	HRS	Substantially Equivalent	GM Dos Reis Industria e Comercio Ltda.	accessdata.fda.gov
November 1, 2024	K242311	EXPERT - Flexible Joint Fixation System	HTN	Substantially Equivalent	GM Dos Reis Industria e Comercio Ltda.	accessdata.fda.gov
June 26, 2024	K232829	Versalock Rib and Sternum Plates System	HRS	Substantially Equivalent	GM Dos Reis Industria e Comercio Ltda.	accessdata.fda.gov
January 12, 2024	K231684	Quick - Radius Disposable Set	HRS	Substantially Equivalent	GM Dos Reis Industria e Comercio Ltda.	accessdata.fda.gov
August 2, 2023	K223114	Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors	MBI	Substantially Equivalent	Gm Dos Reis Industria E Comerico Ltda.	accessdata.fda.gov
June 12, 2023	K230397	Cut Screw - Percutaneous Compression Screw	HWC	Substantially Equivalent	GM Dos Reis Industria e Comercio Ltda.	accessdata.fda.gov
March 8, 2021	K201728	Versalock Periprosthetic Femur Plates System-GMReis	HRS	Substantially Equivalent	GM Dos Reis Industria e Comercio Ltda.	accessdata.fda.gov
October 29, 2020	K200332	EXPERT - Joint Fixation System	HTN	Substantially Equivalent	GM Dos Reis Industria e Comercio Ltda.	accessdata.fda.gov
December 23, 2019	K182718	Mini and Micro Fragments Reconstruction System GMReis	HRS	Substantially Equivalent	Gm Dos Reis Industria E Comerico Ltda.	accessdata.fda.gov
February 1, 2019	K180626	Pedimax II - Pedicular Screw Spinal System	NKB	Substantially Equivalent	Gm Dos Reis Industria E Comerico Ltda.	accessdata.fda.gov

Compare with other makers

Updated August 22, 2026. 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.