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510(k) K200384

Device
HipXpert 3D Display And Anchoring Application
Applicant
Surgical Planning Associates, Inc
510(k) number
K200384
Product code
OSF  
Decision
Substantially Equivalent (SESE)
Decision date
2021-01-28
Date received
2020-02-18
Regulation
882.4560
Classification name
Patient Specific Manual Orthopedic Stereotaxic System
Medical specialty
Neurology
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Stephen B Murphy
Address
New England Baptist Hospital 125 Parker Hill Ave. Suite 545 Boston MA US 02120 02120

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OSF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K233315HipXpert and HipInsight SystemSurgical Planning Associates, Inc.2024-08-08
K093491HIP SEXTANT INSTRUMENT SYSTEMSurgical Planning Associates2010-12-09

Legacy Summary#

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FDA Review#

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