Data / Medical devices / United States / Ortho Max Inc

Ortho Max Inc: FDA-registered device maker in Palm City, FL, United States, 7 510(k) clearances

Name: Ortho Max Inc FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Ortho Max Inc is registered with the FDA (registration 3013843230) in Palm City, FL, United States. It lists 4 device types. The FDA files 7 510(k) clearances under its listings, the newest dated March 17, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3013843230
Address: 4211 Sw High Meadows Ave, Palm City, FL, United States, 34990
Owner or operator: Ortho Max Inc (10095220)
Roles: Complaint file establishment
First device listed: May 21, 2026
Registered through: 2026
Brand names listed: ACL Reamer - 10mm, ACL Reamer - 11mm, ACL Reamer - 12mm, ACL Reamer - 13mm, ACL Reamer - 6mm, ACL Reamer - 7mm, ACL Reamer - 8mm, ACL Reamer - 9mm and more

Devices it lists

Device	Product code	Class	Role	Source
Fastener, Fixation, Nondegradable, Soft Tissue	MBI	2	Complaint file establishment	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Complaint file establishment	accessdata.fda.gov
Plate, Fixation, Bone	HRS	2	Complaint file establishment	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Complaint file establishment	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
March 17, 2026	K260390	Super Upper Limbs Versalock Plating System	HRS	Substantially Equivalent	GM Dos Reis Industria e Comercio Ltda.	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
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
December 23, 2019	K182718	Mini and Micro Fragments Reconstruction System GMReis	HRS	Substantially Equivalent	Gm Dos Reis Industria E Comerico Ltda.	accessdata.fda.gov

Compare with other makers

Updated March 17, 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.