Clearance Summary
Affirm 400 received FDA 510(k) clearance under submission number K251286, sponsored by Digital Surgery Systems, Inc. (D.B.A True Digital Surgery). The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2026-01-21.
- Submission: K251286
- Applicant / Sponsor: Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4950
- Decision date: 2026-01-21
Classification & Regulation
This clearance is catalogued under FDA product code QFX and 21 CFR 882.4950, within the Neurology review panel as a Class II device.