HipXpert 3D Display And Anchoring Application

Patient Specific Manual Orthopedic Stereotaxic System

Surgical Planning Associates, Inc

The following data is part of a premarket notification filed by Surgical Planning Associates, Inc with the FDA for Hipxpert 3d Display And Anchoring Application.

Pre-market Notification Details

Device IDK200384
510k NumberK200384
Device Name:HipXpert 3D Display And Anchoring Application
ClassificationPatient Specific Manual Orthopedic Stereotaxic System
Applicant Surgical Planning Associates, Inc New England Baptist Hospital, 125 Parker Hill Ave Suite 545 Boston,  MA  02120
ContactStephen B Murphy
CorrespondentKellen Hills
Orchid Design 80 Shelton Technology Center Shelton,  CT  06484
Product CodeOSF  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-18
Decision Date2021-01-28

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