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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K180675

Atlas Spine Expandable Cervical Interbody System · Atlas Spine, Inc. · decided 2018-06-13 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
HiJAK™ Cervical2019-08-0010ATLAS SPINE, INC.ODPM68120190800100
HiJAK™ Cervical2019-04-0008ATLAS SPINE, INC.ODPM68120190400080
HiJAK™ Cervical1119-01-0012ATLAS SPINE, INC.ODPM68111190100120
HiJAK™ Cervical1119-02-0013ATLAS SPINE, INC.ODPM68111190200130
HiJAK™ Cervical1119-03-0014ATLAS SPINE, INC.ODPM68111190300140
HiJAK™ Cervical2019-01-0020ATLAS SPINE, INC.ODPM68120190100200
HiJAK™ Cervical2019-08-0013ATLAS SPINE, INC.ODPM68120190800130
HiJAK™ Cervical1119-10-0010ATLAS SPINE, INC.ODPM68111191000100
HiJAK™ Cervical1119-08-0012ATLAS SPINE, INC.ODPM68111190800120
HiJAK™ Cervical2019-01-0013ATLAS SPINE, INC.ODPM68120190100130
HiJAK™ Cervical1119-01-0007ATLAS SPINE, INC.ODPM68111190100070
HiJAK™ Cervical2019-06-0013ATLAS SPINE, INC.ODPM68120190600130
HiJAK™ Cervical2019-04-0009ATLAS SPINE, INC.ODPM68120190400090
HiJAK™ Cervical2019-06-0011ATLAS SPINE, INC.ODPM68120190600110
HiJAK™ Cervical1119-02-0009ATLAS SPINE, INC.ODPM68111190200090
HiJAK™ Cervical2019-01-0011ATLAS SPINE, INC.ODPM68120190100110
HiJAK™ Cervical1119-09-0014ATLAS SPINE, INC.ODPM68111190900140
HiJAK™ Cervical2019-07-0009ATLAS SPINE, INC.ODPM68120190700090
HiJAK™ Cervical2019-02-0013ATLAS SPINE, INC.ODPM68120190200130
HiJAK™ Cervical1119-10-0012ATLAS SPINE, INC.ODPM68111191000120
HiJAK™ Cervical1119-02-0012ATLAS SPINE, INC.ODPM68111190200120
HiJAK™ Cervical2019-04-0013ATLAS SPINE, INC.ODPM68120190400130
HiJAK™ Cervical1119-08-0013ATLAS SPINE, INC.ODPM68111190800130
HiJAK™ Cervical1119-02-0007ATLAS SPINE, INC.ODPM68111190200070
HiJAK™ Cervical1119-07-0010ATLAS SPINE, INC.ODPM68111190700100