FDA 510(k), K200384, HipXpert 3D Display and Anchoring Application

FDA 510(k), K200384, HipXpert 3D Display and Anchoring Application

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510(K) Number: K200384
Device Name: HipXpert 3D Display and Anchoring Application
Manufacturer: Stephen B Murphy
Device Classification Name: Patient Specific Manual Orthopedic Stereotaxic System
Regulation Number: OSF
Classification Product Code: KXA
Date Received: 02/18/2020
Decision Date: 01/28/2021
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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