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510(k) K093491

Device
HIP SEXTANT INSTRUMENT SYSTEM
Applicant
SURGICAL PLANNING ASSOCIATES
510(k) number
K093491
Product code
OSF  
Decision
Substantially Equivalent (SESE)
Decision date
2010-12-09
Date received
2009-11-10
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
JOSEPH AZARY
Address
80 Shelton Technology Center Medford MA US 02155 02155

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
K200384HipXpert 3D Display and Anchoring ApplicationSurgical Planning Associates, Inc.2021-01-28

Legacy Summary#

summary

FDA Review#

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