Data / Medical devices / United States / Digital Surgery Systems, Inc
Digital Surgery Systems, Inc: FDA-registered device maker in Goleta, CA, United States, 1 510(k) clearance
Digital Surgery Systems, Inc is registered with the FDA (registration 3015180671) in Goleta, CA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 27, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015180671
- Address
- 125 Cremona Drive, Suite 110, Goleta, CA, United States, 93117
- Owner or operator
- Digital Surgery Systems (10059141)
- Roles
- Manufacturer, Remanufacturer
- First device listed
- June 25, 2021
- Registered through
- 2026
- Brand names listed
- Affirm 800, RE3 and accessories;
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Microscope, Surgical, General & Plastic Surgery | FSO | 1 | Manufacturer, Remanufacturer | accessdata.fda.gov |
| System, X-Ray, Angiographic | IZI | 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 27, 2025 | K243077 | Affirm 800 | IZI | Substantially Equivalent | Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) | accessdata.fda.gov |
Compare with other makers
- All makers of Microscope, Surgical, General & Plastic Surgery
- All makers of System, X-Ray, Angiographic
Updated June 27, 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.