Data / Medical devices / United States / Biosculptor Corporation
Biosculptor Corporation: FDA-registered device maker in Hialeah, FL, United States, 1 510(k) clearance
Biosculptor Corporation is registered with the FDA (registration 1000560772) in Hialeah, FL, United States. It lists 8 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 27, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1000560772
- Address
- 2480 W 82nd St Unit 1, Hialeah, FL, United States, 33016
- Owner or operator
- BioSculptor Corporation (10028416)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- January 28, 2009
- Registered through
- 2026
- Brand names listed
- BioSculptor kinderBAND, CAMLab Cranial Orthosis Helmet, CFB, EO, EO-SG, FC, FFB, HFB, HFB-OS, HFB-SG, CUS, STS, TGS, WH, WHCS, WHFS, WHH,WHT, WHTF, DynAFO Ankle Foot Orthosis, Femur Splint, Tibia Splint, Maramed, Maramed Orthopedic System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Joint, Ankle, External Brace | ITW | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Orthosis, Cranial | MVA | 2 | Manufacturer | accessdata.fda.gov |
| Orthosis, Cranial, Laser Scan | OAN | 2 | Manufacturer | accessdata.fda.gov |
| Orthosis, Foot Drop | OHI | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Orthosis, Limb Brace | IQI | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Splint, Extremity, Noninflatable, External, Sterile | FYH | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Splint, Hand, And Components | ILH | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Splint, Traction | HSP | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 27, 2009 | K081787 | CAMLAB CRANIAL ORTHOSIS HELMET | OAN | Substantially Equivalent | Biosculptor Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Splint, Traction
- All makers of Orthosis, Foot Drop
- All makers of Orthosis, Limb Brace
- All makers of Splint, Extremity, Noninflatable, External, Sterile
- All makers of Orthosis, Cranial, Laser Scan
- All makers of Orthosis, Cranial
Updated January 27, 2009. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.