Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1058152

FEI Number

1000222089

Entity Name

ORTHOMERICA PRODUCTS, INC.

City/State/Country

ORLANDO, FL, US

Establishment Address

6333 N Orange Blossom Trl, ORLANDO, FL 32810, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ORTHOMERICA PRODUCTS, INC. (Owner Number: 9007946)

Owner / Operator Contact Address

6333 NORTH ORANGE BLOSSOM, TRAIL, Orlando, FL 32810, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K021207

PMA Number

N/A

All Registered Proprietary Names

PAL-Guard STARlight PRO Clarren Helmet (Orthomerica) STARlight UFO Ischial Containment Femoral Kit Orlando LIte KAFO Newport Shoulder Post-Op Tibial Fracture Brace Soft Humeral Fracture Brace Kit Tibial Fracture Brace Ulnar Fracture Brace Kit Ultra Lite Airplane Splint Elbow Orthosis Humeral Fracture Brace Kit Shoulder Humeral Fracture Brace Orlando TPFx Orlando KAFO Prime Elbow Femoral Fracture Brace Pediatric Hip Abduction Splint Newport Jr. STARband Post-Op STARband 3D Starband, Starlight, St. Louis Band STARlight Cranial Orthosis STARband Cranial Orthosis Knee Ankle Foot Orthosis Polaris KC Combo Newport ULTRA VersaROM Hip Newport Full Figure California Hip Orlando TPFx HKAFO Newport 4 Newport 3 Newport MC Orlando HKAFO Orlando Lite HKAFO Newport Lite WHO Forefoot WHO Chopart WHO Heel WHO Articulating Forefoot WHO Midfoot Shark-o OWLS Lite Fracture Brace Show Insert Custom Ankle Foot Orthosis HealPRO Solid Ankle Shoe Insert Fuzion AFO CrowWalker TC Flex Spectrum Adjustable Single Axis Shoe Insert Spectrum Gauntlet California Catalina Custom Fit Fuzion Spinal Custom Orthosis California High Profile TLSO Kydex Knight Taylor California Laguna California Ventura Custom Spinal Orthosis California Soft Spinal California CPO Airback Stock Spinal Orthosis California Chairback Torso Lite LSO Scoliosis Torso LSO Kydex Chairback California Catalina California Mid-Profile COSMIC Starband, Starlight, St. Louis Band STARband, STARlight PEDIATRIC METATARSUS ADDUCTUS BRACE Starband Orthomerica Wooden Cranial Caliper Q-Cap Cranial Protective Orthosis A-Flex STARlight STARlight Cranial RemoldingOrthosis

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IPM	Cover, Limb	Physical Medicine	Class 1	890.3025	2012-12-10
OAN	Orthosis, Cranial, Laser Scan	Neurology	Class 2	882.5970	2009-12-03
OAN	Orthosis, Cranial, Laser Scan	Neurology	Class 2	882.5970	2007-12-17
MVA	Orthosis, Cranial	Neurology	Class 2	882.5970	2009-12-03
OAN	Orthosis, Cranial, Laser Scan	Neurology	Class 2	882.5970	2009-12-03
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2007-03-16
IOZ	Splint, Abduction, Congenital Hip Dislocation	Physical Medicine	Class 1	890.3665	1994-01-07
OAN	Orthosis, Cranial, Laser Scan	Neurology	Class 2	882.5970	2008-12-08
MVA	Orthosis, Cranial	Neurology	Class 2	882.5970	2008-12-08
OAN	Orthosis, Cranial, Laser Scan	Neurology	Class 2	882.5970	2024-04-08
MVA	Orthosis, Cranial	Neurology	Class 2	882.5970	2024-04-08
MVA	Orthosis, Cranial	Neurology	Class 2	882.5970	2020-02-26
OAN	Orthosis, Cranial, Laser Scan	Neurology	Class 2	882.5970	2020-02-26
OAN	Orthosis, Cranial, Laser Scan	Neurology	Class 2	882.5970	2008-11-24
MVA	Orthosis, Cranial	Neurology	Class 2	882.5970	2008-11-24
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	1994-10-05
OAN	Orthosis, Cranial, Laser Scan	Neurology	Class 2	882.5970	2015-03-31
MVA	Orthosis, Cranial	Neurology	Class 2	882.5970	2015-03-31
ITS	Joint, Hip, External Brace	Physical Medicine	Class 1	890.3475	1994-01-07
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2006-10-25
KQZ	Component, Traction, Non-Invasive	Orthopedic	Class 1	888.5890	2013-03-21
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2012-12-10
OAN	Orthosis, Cranial, Laser Scan	Neurology	Class 2	882.5970	2022-02-23
MVA	Orthosis, Cranial	Neurology	Class 2	882.5970	2022-02-23
OAN	Orthosis, Cranial, Laser Scan	Neurology	Class 2	882.5970	2016-08-19
MVA	Orthosis, Cranial	Neurology	Class 2	882.5970	2016-08-19
OAN	Orthosis, Cranial, Laser Scan	Neurology	Class 2	882.5970	2015-03-31
MVA	Orthosis, Cranial	Neurology	Class 2	882.5970	2015-03-31
ITN	Splint, Denis Brown	Physical Medicine	Class 1	890.3675	1994-10-05
OAN	Orthosis, Cranial, Laser Scan	Neurology	Class 2	882.5970	2022-02-23
MVA	Orthosis, Cranial	Neurology	Class 2	882.5970	2022-02-23
KTZ	Caliper	Orthopedic	Class 1	888.4150	2021-07-07
NDA	Helmet, Cranial, For Protective Use	Physical Medicine	Class 1	890.3025	2011-04-05
OAN	Orthosis, Cranial, Laser Scan	Neurology	Class 2	882.5970	2007-12-17

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ORTHOMERICA PRODUCTS, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1058152. Last updated year: 2026. Please use registration number 1058152 when referencing this establishment in official correspondence.