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510(k) K160958

Device
Battalion Universal Spacer System
Applicant
ALPHATEC SPINE
510(k) number
K160958
Product code
PHM  
Decision
Substantially Equivalent (SESE)
Decision date
2016-09-08
Date received
2016-04-05
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
MARY FUNK
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
K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018-05-31
K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015-06-17

Legacy Summary#

summary

FDA Review#

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