Axiom PSR System— 510(k) K223326

Substantially Equivalent

Restor3D

FDA 510(k) clearance K223326 for Axiom PSR System, Substantially Equivalent on 2023-03-30. Applicant: Restor3D.

Clearance details

Applicant: Restor3D
Product code: Code OYK
Advisory panel: Orthopedic
Date received: 2022-10-31
Decision date: 2023-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.