Data / Medical devices / United States / Orbis Medical, LLC
Orbis Medical, LLC: FDA-registered device maker in Palmetto Bay, FL, United States, 1 510(k) clearance
Orbis Medical, LLC is registered with the FDA (registration 3010131978) in Palmetto Bay, FL, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 20, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010131978
- Address
- 17125 SW 81st Ct, Palmetto Bay, FL, United States, 33157
- Owner or operator
- Orbis Medical, LLC (10043155)
- Roles
- Specification developer
- First device listed
- January 28, 2013
- Registered through
- 2026
- Brand names listed
- Drill Bit, External Fixation System, General Manual Instruments, Surgical Tray
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bit, Drill | HTW | 1 | Specification developer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Specification developer | accessdata.fda.gov |
| System, External Fixator (With Metallic Invasive Components) | NDK | 2 | Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| December 20, 2012 | K122208 | EXTERNAL FIXATOR SYSTEM | NDK | Substantially Equivalent | Christopher D. Endara | accessdata.fda.gov |
Compare with other makers
- All makers of Tray, Surgical, Instrument
- All makers of Bit, Drill
- All makers of Instrument, Manual, Surgical, General Use
Updated December 20, 2012. 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.