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510(k) K180480

Device
ATEC Universal Spacer System
Applicant
Alphatec Spine, Inc
510(k) number
K180480
Product code
PHM  
Decision
Substantially Equivalent (SESE)
Decision date
2018-05-31
Date received
2018-02-23
Regulation
888.3080
Classification name
Intervertebral Fusion Device With Bone Graft, Thoracic
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jeremy Markovich
Address
5818 El Camino Real Carlsnad CA US 92008 92008

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PHM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K160958Battalion Universal Spacer SystemAlphatec Spine2016-09-08
K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015-06-17

Legacy Summary#

summary

FDA Review#

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