Data / Medical devices / United States / DePuy Synthes West Palm Beach
DePuy Synthes West Palm Beach: FDA-registered device maker in West Palm Beach, FL, United States, 4 510(k) clearances
DePuy Synthes West Palm Beach is registered with the FDA (registration 3025110439) in West Palm Beach, FL, United States. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated June 14, 2024. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3025110439
- Address
- 374 N Haverhill Rd Ste 400, West Palm Beach, FL, United States, 33415
- Owner or operator
- THE ANSPACH EFFORT, INC. (1045834)
- Roles
- Manufacturer
- First device listed
- September 26, 2024
- Registered through
- 2027
- Brand names listed
- Teligen, VELYS, VELYS(TM)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Camera, Surgical And Accessories | KQM | 1 | Manufacturer | accessdata.fda.gov |
| Cart, Emergency, Cardiopulmonary (Excluding Equipment) | BZN | 1 | Manufacturer | accessdata.fda.gov |
| Orthopedic Stereotaxic Instrument | OLO | 2 | 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 |
|---|---|---|---|---|---|---|
| June 14, 2024 | K233228 | Spine Navigation and Robotic-Assistance Device | OLO | Substantially Equivalent | Ecential Robotics | accessdata.fda.gov |
| June 5, 2024 | K240211 | VELYS Robotic-Assisted Solution | OLO | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| December 14, 2023 | K233227 | VELYS Robotic-Assisted Solution | OLO | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| January 14, 2021 | K202769 | VELYS Robotic-Assisted Solution | OLO | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
Compare with other makers
- All makers of Camera, Surgical And Accessories
- All makers of Orthopedic Stereotaxic Instrument
- All makers of Cart, Emergency, Cardiopulmonary (Excluding Equipment)
Updated June 14, 2024. 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.