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). Device class: 2.
Clearance details
- Applicant
- Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)
- Product code
- Code QFX
- Device class
- Class 2
- Regulation
- 21 CFR 882.4950
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Goleta, CA, US
Recent devices under product code QFX
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