Data / Medical devices / United States / BioDynamik
BioDynamik: FDA-registered device maker in Lake Forest, CA, United States, 1 510(k) clearance
BioDynamik is registered with the FDA (registration 3030966822) in Lake Forest, CA, United States. It lists 7 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 22, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3030966822
- Address
- 11 Orchard Ste 102, Lake Forest, CA, United States, 92630
- Owner or operator
- BioDynamik, Inc (10091366)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- September 6, 2024
- Registered through
- 2027
- Brand names listed
- LOCKING BOLT, PERIOSTEAL ELEVATOR
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Elevator | HTE | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | KIJ | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Pin, Fixation, Threaded | JDW | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Template | HWT | 1 | Complaint file establishment, 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 22, 2025 | K241357 | XT3 System | JDW | Substantially Equivalent | Biodynamik, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Screwdriver
- All makers of Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
- All makers of Elevator
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Template
- All makers of Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Updated January 22, 2025. 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.