Orthomerica Products Inc

FDA Filings

This page includes the latest FDA filings for Orthomerica Products Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Orthomerica Products Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number1058152
FEI Number1000222089
NameORTHOMERICA PRODUCTS, INC.
Owner & OperatorORTHOMERICA PRODUCTS, INC.
Contact Address6333 NORTH ORANGE BLOSSOM TRAIL
Orlando FL 32810 US
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address6333 N Orange Blossom Trl
ORLANDO, FL 32810 US
Establishment Type
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility



FDA Filings

Device
Company
DeviceDate
ORTHOMERICA PRODUCTS, INC.
STARband® 3D 766.10A2024-10-25
ORTHOMERICA PRODUCTS, INC.
STARband® 3D 765.10A2024-10-25
ORTHOMERICA PRODUCTS, INC.
STARband® 3D 764.10A2024-10-25
ORTHOMERICA PRODUCTS, INC.
STARband® 3D 763.10A2024-10-25
ORTHOMERICA PRODUCTS, INC.
STARband® 3D 762.10A2024-10-25
ORTHOMERICA PRODUCTS, INC.
STARband® 766PA2023-07-07
ORTHOMERICA PRODUCTS, INC.
STARband® 766A2023-07-07
ORTHOMERICA PRODUCTS, INC.
STARband® Plus 766.09PA2023-07-07
ORTHOMERICA PRODUCTS, INC.
STARband® Plus 766.09A2023-07-07
ORTHOMERICA PRODUCTS, INC.
STARlight® PRO 766.07PA2023-07-07
ORTHOMERICA PRODUCTS, INC.
STARband® Bi-Valve 766.06PA2023-07-07
ORTHOMERICA PRODUCTS, INC.
STARband® Bi-Valve 766.06A2023-07-07
ORTHOMERICA PRODUCTS, INC.
STARlight® 766.03PA2023-07-07
ORTHOMERICA PRODUCTS, INC.
STARlight® 766.03A2023-07-07
ORTHOMERICA PRODUCTS, INC.
STARlight® Bi-Valve 766.01PA2023-07-07
ORTHOMERICA PRODUCTS, INC.
STARlight® Bi-Valve 766.01A2023-07-07
ORTHOMERICA PRODUCTS, INC.
STARband® Plus 765.09PA2023-07-07
ORTHOMERICA PRODUCTS, INC.
STARband® Plus 765.09A2023-07-07
ORTHOMERICA PRODUCTS, INC.
STARband® Plus 764.09PA2023-07-07
ORTHOMERICA PRODUCTS, INC.
STARband® Plus 764.09A2023-07-07
ORTHOMERICA PRODUCTS, INC.
STARband® Plus 763.09PA2023-07-07
ORTHOMERICA PRODUCTS, INC.
STARband® Plus 763.09A2023-07-07
ORTHOMERICA PRODUCTS, INC.
STARband® Plus 762.09PA2023-07-07
ORTHOMERICA PRODUCTS, INC.
STARband® Plus 762.09A2023-07-07
ORTHOMERICA PRODUCTS, INC.
STARband® Plus 761.09PA2023-07-07
ORTHOMERICA PRODUCTS, INC.
STARband® Plus 761.09A2023-07-07
ORTHOMERICA PRODUCTS, INC.
STARband® Plus 760.09PA2023-07-07
ORTHOMERICA PRODUCTS, INC.
STARband® Plus 760.09A2023-07-07
ORTHOMERICA PRODUCTS, INC.
STARband® 3D 709.10A2023-07-07
ORTHOMERICA PRODUCTS, INC.
STARband® Plus 709.09PA2023-07-07
ORTHOMERICA PRODUCTS, INC.
STARband® Plus 709.09A2023-07-07
ORTHOMERICA PRODUCTS, INC.
STARband® Plus 704.09PA2023-07-07
ORTHOMERICA PRODUCTS, INC.
STARband® Plus 704.09A2023-07-07
ORTHOMERICA PRODUCTS, INC.
STARband® Plus 703.09PA2023-07-07
ORTHOMERICA PRODUCTS, INC.
STARband® Plus 703.09A2023-07-07
ORTHOMERICA PRODUCTS, INC.
Starband, Starlight, St. Louis Band2020-02-26
ORTHOMERICA PRODUCTS, INC.
Starband, Starlight, St. Louis Band2020-02-26
ORTHOMERICA PRODUCTS, INC.
STARband® 765PA2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARband® 765A2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARlight® PRO 765.07PA2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARband® Bi-Valve 765.06PA2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARband® Bi-Valve 765.06A2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARlight® 765.03PA2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARlight® 765.03A2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARlight® Bi-Valve 765.01PA2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARlight® Bi-Valve 765.01A2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARband® 764PA2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARband® 764A2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARlight® PRO 764.07PA2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARband® Bi-Valve 764.06PA2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARband® Bi-Valve 764.06A2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARlight® 764.03PA2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARlight® 764.03A2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARlight® Bi-Valve 764.01PA2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARlight® Bi-Valve 764.01A2018-07-06
ORTHOMERICA PRODUCTS, INC.
St. Louis Band 763.08PA2018-07-06
ORTHOMERICA PRODUCTS, INC.
St. Louis Band 763.08A2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARband® 760PA2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARband® 760A2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARlight® PRO 760.07PA2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARband® Bi-Valve 760.06PA2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARband® Bi-Valve 760.06A2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARlight® 760.03PA2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARlight® 760.03A2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARlight® Bi-Valve 760.01PA2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARlight® Bi-Valve 760.01A2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARband® 709PA2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARband® 709A2018-07-06
ORTHOMERICA PRODUCTS, INC.
St. Louis Band 709.08PA2018-07-06
ORTHOMERICA PRODUCTS, INC.
St. Louis Band 709.08A2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARlight® PRO 709.07PA2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARband® Bi-Valve 709.06PA2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARband® Bi-Valve 709.06A2018-07-06
ORTHOMERICA PRODUCTS, INC.
Clarren Helmet 709.05A2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARlight® 709.03PA2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARlight® 709.03A2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARlight® Bi-Valve 709.01PA2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARlight® Bi-Valve 709.01A2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARband® 704PA2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARband® 704A2018-07-06
ORTHOMERICA PRODUCTS, INC.
St. Louis Band 704.08PA2018-07-06
ORTHOMERICA PRODUCTS, INC.
St. Louis Band 704.08A2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARlight® PRO 704.07PA2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARband® Bi-Valve 704.06PA2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARband® Bi-Valve 704.06A2018-07-06
ORTHOMERICA PRODUCTS, INC.
Clarren Helmet 704.05A2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARlight® 704.03PA2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARlight® 704.03A2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARlight® Bi-Valve 704.01PA2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARlight® Bi-Valve 704.01A2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARband® 703PA2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARband® 703A2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARlight® PRO 703.07PA2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARband® Bi-Valve 703.06PA2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARband® Bi-Valve 703.06A2018-07-06
ORTHOMERICA PRODUCTS, INC.
Clarren Helmet 703.05A2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARlight® 703.03PA2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARlight® 703.03A2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARlight® Bi-Valve 703.01PA2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARlight® Bi-Valve 703.01A2018-07-06
ORTHOMERICA PRODUCTS, INC.
STARlight® Bi-Valve 761.01PA2018-03-29
ORTHOMERICA PRODUCTS, INC.
STARlight® Bi-Valve 761.01A2018-03-29
Orthomerica Products, Inc
STARband, STARlight, St. Louis Band2018-03-01
ORTHOMERICA PRODUCTS, INC.
St. LOUIS Band2016-08-19
ORTHOMERICA PRODUCTS, INC.
St. LOUIS Band2016-08-19
ORTHOMERICA PRODUCTS, INC.
STARband, STARlight2016-08-19
ORTHOMERICA PRODUCTS, INC.
STARband, STARlight2016-08-19
ORTHOMERICA PRODUCTS, INC.
St. Louis Band2016-07-20
ORTHOMERICA PRODUCTS, INC.
STARband, STARlight2015-12-10
ORTHOMERICA PRODUCTS, INC.
STARband, STARlight2015-12-10
ORTHOMERICA PRODUCTS, INC.
STARband, STARlight2015-09-18
ORTHOMERICA PRODUCTS, INC.
STARband, STARlight2015-07-01
ORTHOMERICA PRODUCTS, INC.
STARBAND, STARLIGHT2015-04-23
ORTHOMERICA PRODUCTS, INC.
STARBAND, STARLIGHT2014-10-06
ORTHOMERICA PRODUCTS, INC.
STARBAND AND STARLIGHT2014-06-06
ORTHOMERICA PRODUCTS, INC.
STARLIGHT2014-01-16
ORTHOMERICA PRODUCTS, INC.
STARBAND2013-06-10
ORTHOMERICA PRODUCTS, INC.
Solid Ankle Shoe Insert2012-12-10
ORTHOMERICA PRODUCTS, INC.
Semi-Solid Ankle Orthosis2012-12-10
ORTHOMERICA PRODUCTS, INC.
Leaf Spring Orthosis2012-12-10
ORTHOMERICA PRODUCTS, INC.
Ankle Foot Orthosis2012-12-10
ORTHOMERICA PRODUCTS, INC.
Torso Lite LSO2012-12-10
ORTHOMERICA PRODUCTS, INC.
Torso LSO2012-12-10
ORTHOMERICA PRODUCTS, INC.
Stock Spinal Orthosis2012-12-10
ORTHOMERICA PRODUCTS, INC.
Scoliosis2012-12-10
ORTHOMERICA PRODUCTS, INC.
Kydex Knight Taylor2012-12-10
ORTHOMERICA PRODUCTS, INC.
Kydex Chairback2012-12-10
ORTHOMERICA PRODUCTS, INC.
Fuzion Spinal Custom Orthosis2012-12-10
ORTHOMERICA PRODUCTS, INC.
Custom Spinal Orthosis2012-12-10
ORTHOMERICA PRODUCTS, INC.
California Ventura2012-12-10
ORTHOMERICA PRODUCTS, INC.
California Soft Spinal2012-12-10
ORTHOMERICA PRODUCTS, INC.
California Mid-Profile2012-12-10
ORTHOMERICA PRODUCTS, INC.
California Laguna2012-12-10
ORTHOMERICA PRODUCTS, INC.
California High Profile TLSO2012-12-10
ORTHOMERICA PRODUCTS, INC.
California Chairback2012-12-10
ORTHOMERICA PRODUCTS, INC.
California Catalina2012-12-10
ORTHOMERICA PRODUCTS, INC.
California Catalina Custom Fit2012-12-10
ORTHOMERICA PRODUCTS, INC.
California CPO2012-12-10
ORTHOMERICA PRODUCTS, INC.
COSMIC2012-12-10
ORTHOMERICA PRODUCTS, INC.
Airback2012-12-10
ORTHOMERICA PRODUCTS, INC.
TORSO TLSO2012-12-10
ORTHOMERICA PRODUCTS, INC.
TORSO Lite TLSO2012-12-10
ORTHOMERICA PRODUCTS, INC.
Quick Fuzion2012-12-10
ORTHOMERICA PRODUCTS, INC.
LOMBAR2012-12-10
ORTHOMERICA PRODUCTS, INC.
Custom Spinal Orthosis2012-12-10
ORTHOMERICA PRODUCTS, INC.
California ECO2012-12-10
ORTHOMERICA PRODUCTS, INC.
California CEO2012-12-10
ORTHOMERICA PRODUCTS, INC.
PAL-Guard2012-12-10
ORTHOMERICA PRODUCTS, INC.
Highlander Shoulder Sling2012-12-10
ORTHOMERICA PRODUCTS, INC.
Elbow Orthosis2012-12-10
ORTHOMERICA PRODUCTS, INC.
Q-Cap2011-04-05
ORTHOMERICA PRODUCTS, INC.
Cranial Protective Orthosis2011-04-05
ORTHOMERICA PRODUCTS, INC.
A-Flex2011-04-05
ORTHOMERICA PRODUCTS, INC.
STARlight PRO2009-12-03
ORTHOMERICA PRODUCTS, INC.
STARlight2009-12-03
ORTHOMERICA PRODUCTS, INC.
STARlight2009-12-03
ORTHOMERICA PRODUCTS, INC.
STARLIGHT2009-07-17
ORTHOMERICA PRODUCTS, INC.
STARband Post-Op2008-12-08
ORTHOMERICA PRODUCTS, INC.
STARband Post-Op2008-12-08
ORTHOMERICA PRODUCTS, INC.
STARBAND2008-12-05
ORTHOMERICA PRODUCTS, INC.
STARlight Cranial Orthosis2008-11-24
ORTHOMERICA PRODUCTS, INC.
STARband Cranial Orthosis2008-11-24
ORTHOMERICA PRODUCTS, INC.
STARlight Cranial Orthosis2008-11-24
ORTHOMERICA PRODUCTS, INC.
STARband Cranial Orthosis2008-11-24
ORTHOMERICA PRODUCTS, INC.
STARLIGHT2008-10-31
ORTHOMERICA PRODUCTS, INC.
STARLIGHT2008-09-12
ORTHOMERICA PRODUCTS, INC.
Clarren Helmet (Orthomerica)2007-12-17
ORTHOMERICA PRODUCTS, INC.
STARlight2007-12-17
ORTHOMERICA PRODUCTS, INC.
STARlight Cranial RemoldingOrthosis2007-12-17
ORTHOMERICA PRODUCTS, INC.
STARscanner2007-12-17
ORTHOMERICA PRODUCTS, INC.
STARband2007-12-17
ORTHOMERICA PRODUCTS, INC.
OPI Band2007-12-17
ORTHOMERICA PRODUCTS, INC.
PREP Prefabricated Adjustable A/K Socket2007-03-16
ORTHOMERICA PRODUCTS, INC.
PREP Adjustable B/K Socket System2007-03-16
ORTHOMERICA PRODUCTS, INC.
Ultra Lite Airplane Splint2007-03-16
ORTHOMERICA PRODUCTS, INC.
Ulnar Fracture Brace Kit2007-03-16
ORTHOMERICA PRODUCTS, INC.
UFO2007-03-16
ORTHOMERICA PRODUCTS, INC.
Tibial Fracture Brace2007-03-16
ORTHOMERICA PRODUCTS, INC.
Soft Humeral Fracture Brace Kit2007-03-16
ORTHOMERICA PRODUCTS, INC.
Shoulder Humeral Fracture Brace2007-03-16
ORTHOMERICA PRODUCTS, INC.
Prime Elbow2007-03-16
ORTHOMERICA PRODUCTS, INC.
Post-Op Tibial Fracture Brace2007-03-16
ORTHOMERICA PRODUCTS, INC.
Orlando TPFx2007-03-16
ORTHOMERICA PRODUCTS, INC.
Orlando LIte KAFO2007-03-16
ORTHOMERICA PRODUCTS, INC.
Orlando KAFO2007-03-16
ORTHOMERICA PRODUCTS, INC.
Newport Shoulder2007-03-16
ORTHOMERICA PRODUCTS, INC.
Ischial Containment Femoral Kit2007-03-16
ORTHOMERICA PRODUCTS, INC.
Humeral Fracture Brace Kit2007-03-16
ORTHOMERICA PRODUCTS, INC.
Femoral Fracture Brace2007-03-16
ORTHOMERICA PRODUCTS, INC.
Elbow Orthosis2007-03-16
ORTHOMERICA PRODUCTS, INC.
Wrist Hand Platform Splint2007-03-16
ORTHOMERICA PRODUCTS, INC.
Wrist Hand Orthosis2007-03-16
ORTHOMERICA PRODUCTS, INC.
Wrist Hand Cock-Up Splint2007-03-16
ORTHOMERICA PRODUCTS, INC.
Gamekeepers Thumb2007-03-16
ORTHOMERICA PRODUCTS, INC.
WHO Midfoot2006-10-25
ORTHOMERICA PRODUCTS, INC.
WHO Heel2006-10-25
ORTHOMERICA PRODUCTS, INC.
WHO Forefoot2006-10-25
ORTHOMERICA PRODUCTS, INC.
WHO Chopart2006-10-25
ORTHOMERICA PRODUCTS, INC.
WHO Articulating Forefoot2006-10-25
ORTHOMERICA PRODUCTS, INC.
TC Flex2006-10-25
ORTHOMERICA PRODUCTS, INC.
Spectrum2006-10-25
ORTHOMERICA PRODUCTS, INC.
Spectrum Gauntlet2006-10-25
ORTHOMERICA PRODUCTS, INC.
Solid Ankle Shoe Insert2006-10-25
ORTHOMERICA PRODUCTS, INC.
Shark-o2006-10-25
ORTHOMERICA PRODUCTS, INC.
OWLS Lite2006-10-25
ORTHOMERICA PRODUCTS, INC.
HealPRO2006-10-25
ORTHOMERICA PRODUCTS, INC.
Fuzion AFO2006-10-25
ORTHOMERICA PRODUCTS, INC.
Fracture Brace Show Insert2006-10-25
ORTHOMERICA PRODUCTS, INC.
Custom Ankle Foot Orthosis2006-10-25
ORTHOMERICA PRODUCTS, INC.
CrowWalker2006-10-25
ORTHOMERICA PRODUCTS, INC.
Adjustable Single Axis Shoe Insert2006-10-25
ORTHOMERICA PRODUCTS, INC.
Supra Lite Cervical2006-10-25
ORTHOMERICA PRODUCTS, INC.
MRI Cervical2006-10-25
ORTHOMERICA PRODUCTS, INC.
LIDO 22006-10-25
ORTHOMERICA PRODUCTS, INC.
California Low Profile LC2006-10-25
ORTHOMERICA PRODUCTS, INC.
California Compressor2006-10-25
ORTHOMERICA PRODUCTS, INC.
California Compression2006-10-25
ORTHOMERICA PRODUCTS, INC.
California C32006-10-25
ORTHOMERICA PRODUCTS, INC.
CLARREN HELMET (ORTHOMERICA)2002-07-25
ORTHOMERICA PRODUCTS, INC.
STARLIGHT2002-07-09
ORTHOMERICA PRODUCTS, INC.
STARBAND CRANIAL ORTHOSIS2001-07-03
ORTHOMERICA PRODUCTS, INC.
OPI BAND2000-07-07
ORTHOMERICA PRODUCTS, INC.
Polaris1994-10-05
ORTHOMERICA PRODUCTS, INC.
Knee Ankle Foot Orthosis1994-10-05
ORTHOMERICA PRODUCTS, INC.
KC Combo1994-10-05
ORTHOMERICA PRODUCTS, INC.
PEDIATRIC METATARSUS ADDUCTUS BRACE1994-10-05
ORTHOMERICA PRODUCTS, INC.
Orlando TPFx HKAFO1994-01-07
ORTHOMERICA PRODUCTS, INC.
Orlando Lite HKAFO1994-01-07
ORTHOMERICA PRODUCTS, INC.
Orlando HKAFO1994-01-07
ORTHOMERICA PRODUCTS, INC.
Newport MC1994-01-07
ORTHOMERICA PRODUCTS, INC.
Newport Lite1994-01-07
ORTHOMERICA PRODUCTS, INC.
Newport Full Figure1994-01-07
ORTHOMERICA PRODUCTS, INC.
Newport 41994-01-07
ORTHOMERICA PRODUCTS, INC.
Newport 31994-01-07
ORTHOMERICA PRODUCTS, INC.
California Hip1994-01-07
ORTHOMERICA PRODUCTS, INC.
Pediatric Hip Abduction Splint1994-01-07
ORTHOMERICA PRODUCTS, INC.
Newport Jr.1994-01-07

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020082631835Genova,Italy -> Miami, FloridaORTHOPEDIC BRACES HTS CODE 90211010 TERMS DAP ORLANDO 32810 FL,USA1 PKG
2020072832329Genova,Italy -> Miami, FloridaORTHOPEDICS BRACES HTS CODE 90211010 TERMS DAP ORLANDO 32810 FL,USA23 CTN
2019012648898London,United Kingdom -> Charleston, South CarolinaPLASTICS & ACCESSORIES1 PCS

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