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

Clearance record K192054

Endoskeleton TAS Plate · Titan Spine, Inc. · decided 2019-08-29 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
ENDOSKELETON® TAS2300-1311MEDTRONIC SOFAMOR DANEK, INC.HWR00191375028239
ENDOSKELETON® TAS2300-1319MEDTRONIC SOFAMOR DANEK, INC.HWR00191375040118
ENDOSKELETON® TAS2300-1304MEDTRONIC SOFAMOR DANEK, INC.HWR00191375028963
ENDOSKELETON® TAS2301-0005TITAN SPINE, LLCOVD00191375050438
ENDOSKELETON® TAS2300-1318MEDTRONIC SOFAMOR DANEK, INC.HWR00191375040101
ENDOSKELETON® TAS2300-1320MEDTRONIC SOFAMOR DANEK, INC.HWR00191375040125
ENDOSKELETON® TAS2300-1305MEDTRONIC SOFAMOR DANEK, INC.HWR00191375028987
ENDOSKELETON® TAS2301-0006TITAN SPINE, LLCOVD00191375050445
ENDOSKELETON® TAS2300-1303MEDTRONIC SOFAMOR DANEK, INC.HWR00191375039983
ENDOSKELETON® TAS2300-1310MEDTRONIC SOFAMOR DANEK, INC.HWR00191375028222