Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000560772

FEI Number

1000560772

Entity Name

BIOSCULPTOR CORPORATION

City/State/Country

Hialeah, FL, US

Establishment Address

2480 W 82nd St Unit 1, Hialeah, FL 33016, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

BioSculptor Corporation (Owner Number: 10028416)

Owner / Operator Contact Address

2480 West 82nd Street, #1, Bay 1A, Hialeah, FL 33016, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Miami Fracture Brace CUS, STS, TGS, WH, WHCS, WHFS, WHH,WHT, WHTF Maramed Orthopedic Systems Maramed Metacarpal Splint Maramed Orthopedic Systems Wrist Hand Holder Miami Fracture Brace Maramed Miami Fracture Brace Maramed DynAFO Ankle Foot Orthosis Maramed Orthopedic Systems Sky Medical Solid Ankle Foot Orthosis, SAFO CFB, EO, EO-SG, FC, FFB, HFB, HFB-OS, HFB-SG TFB, TFB-PS, UFB Maramed Plastic Colles Splint, Plastic Femur Splint, Plastic Forearm Splint, Plastic Tibia Splint Maramed Orthopedic Systems Miami Fracture Brace Plastic Tibia/Fibula Splint Sky Medical Humeral Fracture Orthosis, HFO Sky Medical Ulna Fracture Brace, UFO Sky Medical Humeral Facture Orthosis Deltoid Extension, HFO-DE PLS-S, PLS-S-OH Miami Fracture Brace PLSC, PLSC-OH PLS-FF, PLS-FF-OH PLSB Maramed Orthopedic System Maramed Sky Medical Ankle Foot Orthosis, AFO Maramed Maramed Orthopedic Systems Femur Splint, Tibia Splint Miami Fracture Brace

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2015-01-05
HSP	Splint, Traction	Orthopedic	Class 1	888.5890	2015-01-05
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2015-01-05
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2015-01-05
OHI	Orthosis, Foot Drop	Physical Medicine	Class 1	890.3475	2015-01-05
FYH	Splint, Extremity, Noninflatable, External, Sterile	General, Plastic Surgery	Class 1	878.3910	2015-01-05

Official Correspondent

Mark Mazloff

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BioSculptor Corporation

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 1000560772. Last updated year: 2026. Please use registration number 1000560772 when referencing this establishment in official correspondence.