FDA 510(k)

Affirm 400

K-Number: K251286 · 2026-01-21

ApplicantDigital Surgery Systems, Inc. (D.B.A True Digital Surgery)

Decision Date2026-01-21

Product CodeQFX

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Affirm 400 is the device name listed in this FDA 510(k) record. The listed applicant is Digital Surgery Systems, Inc. (D.B.A True Digital Surgery). It received FDA 510(k) clearance on 2026-01-21 under 510(k) number K251286. The device is classified under product code QFX. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Affirm 400?

Affirm 400 is a medical device that received FDA 510(k) clearance on 2026-01-21. The listed applicant is Digital Surgery Systems, Inc. (D.B.A True Digital Surgery). The 510(k) number is K251286.

When did Affirm 400 receive FDA 510(k) clearance?

Affirm 400 received FDA 510(k) clearance on 2026-01-21, under 510(k) number K251286.

Who is the listed applicant for Affirm 400?

The FDA 510(k) record lists Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Affirm 400?

The FDA product code for Affirm 400 is QFX.

Other records listing Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243077Affirm 800

Related Devices (Code: QFX)

K240215BLUE 400; BLUE 400 SCarl Zeiss Meditec, AG K232567Myriad SPECTRA Light SourceNico Corporation K211346BLUE 400Carl Zeiss Meditec, AG

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.