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FDA 510(k)

Affirm 800

K-Number: K243077 · 2025-06-27

ApplicantDigital Surgery Systems, Inc. (D.B.A True Digital Surgery)
Decision Date2025-06-27
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Affirm 800 is a medical device manufactured by Digital Surgery Systems, Inc. (D.B.A True Digital Surgery). It received FDA 510(k) clearance on 2025-06-27 under approval number K243077. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Affirm 800?

Affirm 800 is a medical device that received FDA 510(k) clearance on 2025-06-27. It is manufactured by Digital Surgery Systems, Inc. (D.B.A True Digital Surgery). The 510(k) number is K243077.

When was Affirm 800 approved by the FDA?

Affirm 800 received FDA 510(k) clearance on 2025-06-27, under approval number K243077.

What company makes Affirm 800?

Affirm 800 is manufactured by Digital Surgery Systems, Inc. (D.B.A True Digital Surgery).

What is the FDA product code for Affirm 800?

The FDA product code for Affirm 800 is IZI.

Other Devices by Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)

K251286Affirm 400

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Official Source

View on FDA Database →

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

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