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Affirm 800

by Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) 510(k)

Active United States

510(k) K243077

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK243077 Date27 Jun 2025ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
IZI
Device Class
Class II
Regulation
21 CFR Part 892.1600
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Other devices from Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)

  • Affirm 400

    Class II