Affirm 400— 510(k) K251286
Substantially EquivalentDigital Surgery Systems, Inc. (D.B.A True Digital Surgery)
FDA 510(k) clearance K251286 for Affirm 400, Substantially Equivalent on 2026-01-21. Applicant: Digital Surgery Systems, Inc. (D.B.A True Digital Surgery).
Clearance details
- Applicant
- Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)
- Product code
- Code QFX
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Goleta, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.