ORTHOMERICA PRODUCTS, INC.

Registration Details

Registration Name: ORTHOMERICA PRODUCTS, INC.
Registration Number: 1058152
FEI Number: 1000222089
Status: Active
Expiry Year: 2026
Initial Importer: Yes
Address: 6333 N Orange Blossom Trl
City: ORLANDO
State: FL
ZIP: 32810
Country: US

Regulatory Submissions

510(k) Number: K090587

Owner / Operator

Firm Name: ORTHOMERICA PRODUCTS, INC.
Operator Number: 9007946
Address: 6333 NORTH ORANGE BLOSSOM, TRAIL
City: Orlando
State: FL
Postal Code: 32810
Country: US

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Cover, Limb	IPM	Class 1	Physical Medicine	No	2012-12-10
Orthosis, Cranial, Laser Scan	OAN	Class 2	Neurology	No	2009-12-03
Orthosis, Cranial	MVA	Class 2	Neurology	No	2009-12-03
Orthosis, Limb Brace	IQI	Class 1	Physical Medicine	No	2007-03-16
Splint, Abduction, Congenital Hip Dislocation	IOZ	Class 1	Physical Medicine	No	1994-01-07
Joint, Knee, External Brace	ITQ	Class 1	Physical Medicine	No	1994-10-05
Joint, Hip, External Brace	ITS	Class 1	Physical Medicine	No	1994-01-07
Joint, Ankle, External Brace	ITW	Class 1	Physical Medicine	No	2006-10-25
Component, Traction, Non-Invasive	KQZ	Class 1	Orthopedic	No	2013-03-21
Orthosis, Lumbar	IQE	Class 1	Physical Medicine	No	2012-12-10
Splint, Denis Brown	ITN	Class 1	Physical Medicine	No	1994-10-05
Caliper	KTZ	Class 1	Orthopedic	No	2021-07-07
Helmet, Cranial, For Protective Use	NDA	Class 1	Physical Medicine	No	2011-04-05
Orthosis, Lumbo-Sacral	IPY	Class 1	Physical Medicine	No	2006-10-25
Orthosis, Foot Drop	OHI	Class 1	Physical Medicine	No	2012-12-10
Sling, Arm, Overhead Supported	ILE	Class 1	Physical Medicine	No	2012-12-10
Orthosis, Cervical	IQK	Class 1	Physical Medicine	No	2006-10-25
Splint, Hand, And Components	ILH	Class 1	Physical Medicine	No	2007-03-16
Prosthesis, Thigh Socket, External Component	ISS	Class 1	Physical Medicine	No	2007-03-16
Orthosis, Thoracic	IPT	Class 1	Physical Medicine	No	2012-12-10

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 PEDIATRIC METATARSUS ADDUCTUS BRACE Starband Orthomerica Wooden Cranial Caliper Q-Cap Cranial Protective Orthosis A-Flex STARlight Cranial RemoldingOrthosis California Compression California C3 California Low Profile LC California Compressor Supra-Lite AFO Carbon Supra-Lite AFO Leaf Spring Orthosis Ankle Foot Orthosis Semi-Solid Ankle Orthosis Highlander Shoulder Sling MRI Cervical Supra Lite Cervical LIDO 2 Wrist Hand Platform Splint Wrist Hand Orthosis Wrist Hand Cock-Up Splint Gamekeepers Thumb STARscanner STARband PREP Adjustable B/K Socket System PREP Prefabricated Adjustable A/K Socket St. LOUIS Band Quick Fuzion California MC Spinal System TORSO Lite TLSO California ECO LOMBAR TORSO TLSO California CEO

Establishment Types

Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer)