FDA Registration
Active
🇺🇸 United States
BIOSCULPTOR CORPORATION
Reg #: 1000560772
·
FEI: 1000560772
·
Expires 2026
Products
8
Proprietary Names
24
Establishment Types
2
Classifications
8
Registration Details
- Registration Name
- BIOSCULPTOR CORPORATION
- Registration Number
- 1000560772
- FEI Number
- 1000560772
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2480 W 82nd St Unit 1
- City
- Hialeah
- State
- FL
- ZIP
- 33016
- Country
- US
Regulatory Submissions
- 510(k) Number
- K081787
Owner / Operator
- Firm Name
- BioSculptor Corporation
- Operator Number
- 10028416
- Address
- 2480 West 82nd Street, #1, Bay 1A
- City
- Hialeah
- State
- FL
- Postal Code
- 33016
- Country
- US
- Correspondent
- Mark J Mazloff
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2015-01-05 |
| Splint, Traction | HSP | Class 1 | Orthopedic | No | 2015-01-05 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2015-01-05 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2015-01-05 |
| Orthosis, Foot Drop | OHI | Class 1 | Physical Medicine | No | 2015-01-05 |
| Splint, Extremity, Noninflatable, External, Sterile | FYH | Class 1 | General, Plastic Surgery | No | 2015-01-05 |
| Orthosis, Cranial, Laser Scan | OAN | Class 2 | Neurology | No | 2009-01-28 |
| Orthosis, Cranial | MVA | Class 2 | Neurology | No | 2009-01-28 |
Proprietary Names
Miami Fracture Brace
CUS, STS, TGS, WH, WHCS, WHFS, WHH,WHT, WHTF
Maramed Orthopedic Systems
Maramed
Metacarpal Splint
Wrist Hand Holder
DynAFO Ankle Foot Orthosis
Sky Medical Solid Ankle Foot Orthosis, SAFO
CFB, EO, EO-SG, FC, FFB, HFB, HFB-OS, HFB-SG
TFB, TFB-PS, UFB
Plastic Colles Splint, Plastic Femur Splint, Plastic Forearm Splint, Plastic Tibia Splint
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
PLSC, PLSC-OH
PLS-FF, PLS-FF-OH
PLSB
Maramed Orthopedic System
Sky Medical Ankle Foot Orthosis, AFO
Femur Splint, Tibia Splint
CAMLab Cranial Orthosis Helmet
BioSculptor kinderBAND
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device