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Data / Medical devices / United States / Orthomerica Products, Inc.

Orthomerica Products, Inc.: FDA-registered device maker in Orlando, FL, United States, 19 510(k) clearances

Orthomerica Products, Inc. is registered with the FDA (registration 1058152) in Orlando, FL, United States. It lists 20 device types. The FDA files 19 510(k) clearances under its listings, the newest dated March 15, 2024. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Orthomerica Products, Inc.
FDA registration number
1058152
FEI number
1000222089
Address
6333 N Orange Blossom Trl, Orlando, FL, United States, 32810
Owner or operator
ORTHOMERICA PRODUCTS, INC. (9007946)
Roles
Contract manufacturer, Manufacturer, Specification developer
First device listed
January 7, 1994
Registered through
2026
Brand names listed
A-Flex, Adjustable Single Axis Shoe Insert, Airback, Ankle Foot Orthosis, COSMIC, California C3, California CEO, California CPO and more

Devices it lists

DeviceProduct codeClassRoleSource
CaliperKTZ1Specification developeraccessdata.fda.gov
Component, Traction, Non-InvasiveKQZ1Manufactureraccessdata.fda.gov
Cover, LimbIPM1Manufactureraccessdata.fda.gov
Helmet, Cranial, For Protective UseNDA1Manufactureraccessdata.fda.gov
Joint, Ankle, External BraceITW1Manufacturer, Specification developeraccessdata.fda.gov
Joint, Hip, External BraceITS1Contract manufacturer, Manufacturer, Specification developeraccessdata.fda.gov
Joint, Knee, External BraceITQ1Manufactureraccessdata.fda.gov
Orthosis, CervicalIQK1Manufactureraccessdata.fda.gov
Orthosis, CranialMVA2Manufacturer, Specification developeraccessdata.fda.gov
Orthosis, Cranial, Laser ScanOAN2Manufacturer, Specification developeraccessdata.fda.gov
Orthosis, Foot DropOHI1Manufactureraccessdata.fda.gov
Orthosis, Limb BraceIQI1Manufactureraccessdata.fda.gov
Orthosis, LumbarIQE1Manufacturer, Specification developeraccessdata.fda.gov
Orthosis, Lumbo-SacralIPY1Manufactureraccessdata.fda.gov
Orthosis, ThoracicIPT1Manufactureraccessdata.fda.gov
Prosthesis, Thigh Socket, External ComponentISS1Manufactureraccessdata.fda.gov
Sling, Arm, Overhead SupportedILE1Manufactureraccessdata.fda.gov
Splint, Abduction, Congenital Hip DislocationIOZ1Manufactureraccessdata.fda.gov
Splint, Denis BrownITN1Manufactureraccessdata.fda.gov
Splint, Hand, And ComponentsILH1Manufactureraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
March 15, 2024K240466STARband 3DOANSubstantially EquivalentOrthomerica Products, Inc.accessdata.fda.gov
April 20, 2023K223238STARband 3DMVASubstantially EquivalentOrthomerica Products, Inc.accessdata.fda.gov
August 17, 2021K211376STARbandOANSubstantially EquivalentOrthomerica Products, Inc.accessdata.fda.gov
April 27, 2021K203098STARband, STARlight, St. Louis BandOANSubstantially EquivalentOrthomerica Products, Inc.accessdata.fda.gov
March 1, 2018K180109STARband, STARlight, St. Louis BandOANSubstantially EquivalentOrthomerica Products, Inc.accessdata.fda.gov
July 20, 2016K161138St. Louis BandOANSubstantially EquivalentOrthomerica Products, Inc.accessdata.fda.gov
September 18, 2015K151979STARband, STARlightOANSubstantially EquivalentOrthomerica Products, Inc.accessdata.fda.gov
July 1, 2015K151147STARband, STARlightOANSubstantially EquivalentOrthomerica Products, Inc.accessdata.fda.gov
October 6, 2014K141842STARBAND, STARLIGHTMVASubstantially EquivalentOrthomerica Products, Inc.accessdata.fda.gov
June 6, 2014K140353STARBAND AND STARLIGHTMVASubstantially EquivalentOrthomerica Products, Inc.accessdata.fda.gov
January 16, 2014K133250STARLIGHTOANSubstantially EquivalentOrthomerica Products, Inc.accessdata.fda.gov
June 10, 2013K124023STARBANDOANSubstantially EquivalentOrthomerica Products, Inc.accessdata.fda.gov
July 17, 2009K090587STARLIGHTOANSubstantially EquivalentOrthomerica Products, Inc.accessdata.fda.gov
December 5, 2008K082950STARBANDOANSubstantially EquivalentOrthomerica Products, Inc.accessdata.fda.gov
October 31, 2008K082945STARLIGHTOANSubstantially EquivalentOrthomerica Products, Inc.accessdata.fda.gov
September 12, 2008K081994STARLIGHTOANSubstantially EquivalentOrthomerica Products, Inc.accessdata.fda.gov
July 25, 2002K021918CLARREN HELMET (ORTHOMERICA)OANSubstantially EquivalentOrthomerica Products, Inc.accessdata.fda.gov
July 9, 2002K021207STARLIGHTOANSubstantially EquivalentOrthomerica Products, Inc.accessdata.fda.gov
July 3, 2001K011350STARBAND CRANIAL ORTHOSISOANSubstantially EquivalentOrthomerica Products, Inc.accessdata.fda.gov

Compare with other makers

Updated March 15, 2024. 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.