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510(k) K131615

Device
POLARIS SPINAL SYSTEM
Applicant
BIOMET SPINE (AKA EBI, LLC)
510(k) number
K131615
Product code
OSH  
Decision
Substantially Equivalent (SESE)
Decision date
2013-09-04
Date received
2013-06-03
Regulation
888.3070
Classification name
Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
VIVIAN KELLY
Address
399 Jefferson Rd. Parsippany NJ US 07054 07054

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OSH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K153446OLYMPIC Posterior Spinal Fixation SystemAstura Medical2016-04-08
K140276CD HORIZON SPINAL SYSTEMMedtronic Sofamor Danek2014-03-13
K132574PASS LP SPINAL SYSTEMMedicrea International2013-11-08
K132303IMPLANET SPINE SYSTEMImplanet, S.A.2013-10-10
K132575PASS LP SPINAL SYSTEMMedicrea International2013-10-03
K131802EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEMDepuy Spine, A Johnson & Johnson Company2013-09-12
K131784RANGE SPINAL SYSTEMK2m, Inc.2013-08-30
K131321CD HORIZON SPINAL SYSTEMMedtronic Sofamor Danek USA2013-06-05
K124058CREO STABILIZATION SYSTEMGlobus Medical, Inc.2013-05-13
K131030RANGE SPINAL SYSTEMK2m, Inc.2013-05-09
K130655RESPONSE SPINE SYSTEMOrthoPediatrics Corp.2013-05-08
K122877RANGE SPINAL SYSTEM, SMALL STATUREK2m, Inc.2013-05-08
K130330RANGE SPINAL SYSTEMK2m, Inc.2013-05-02
K123412RANGE SPINAL SYSTEM, SMALL STRATURE COMPONENTSK2m, Inc.2013-02-13
K123138PASS LP SPINAL SYSTEMMedicrea International2013-02-05

Legacy Summary#

summary

FDA Review#

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