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510(k) K150994

Device
NuVasive CoRoent Thoracolumbar Implants
Applicant
NUVASIVE, INCORPORATED
510(k) number
K150994
Product code
PHM  
Decision
Substantially Equivalent (SESE)
Decision date
2015-06-17
Date received
2015-04-15
Regulation
888.3080
Classification name
Intervertebral Fusion Device With Bone Graft, Thoracic
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
CYNTHIA ADAMS
Address
7475 Lusk Blvd. San Diego CA US 92121 92121

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
K160958Battalion Universal Spacer SystemAlphatec Spine2016-09-08

Legacy Summary#

summary

FDA Review#

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