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

Clearance record K091797

TSRH SPINAL SYSTEM · Medtronic Sofamor Danek · decided 2010-04-30 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
TSRH® Spinal SystemX0209494MEDTRONIC SOFAMOR DANEK, INC.KWP MNH MNI NKB00613994576507
TSRH® Spinal System83545609HMEDTRONIC SOFAMOR DANEK, INC.KWP MNH MNI NKB00613994888228
TSRH® Spinal System83545459HMEDTRONIC SOFAMOR DANEK, INC.KWP MNH MNI NKB00613994888198
TSRH® Spinal System83575609HMEDTRONIC SOFAMOR DANEK, INC.KWP MNH MNI NKB00613994888037
TSRH® Spinal SystemX0209503MEDTRONIC SOFAMOR DANEK, INC.KWP MNH MNI NKB00613994576811
TSRH® Spinal System83585609HMEDTRONIC SOFAMOR DANEK, INC.KWP MNH MNI NKB00613994888129
TSRH® Spinal System83545259HMEDTRONIC SOFAMOR DANEK, INC.KWP MNH MNI NKB00613994888150
TSRH® Spinal System83575359HMEDTRONIC SOFAMOR DANEK, INC.KWP MNH MNI NKB00613994887986
TSRH® Spinal SystemX0209475MEDTRONIC SOFAMOR DANEK, INC.KWP MNH MNI NKB00613994577092
TSRH® Spinal SystemX0209491MEDTRONIC SOFAMOR DANEK, INC.KWP MNH MNI NKB00613994576538
TSRH® Spinal SystemX0209458MEDTRONIC SOFAMOR DANEK, INC.KWP MNH MNI NKB00613994577269
TSRH® Spinal SystemX0209496MEDTRONIC SOFAMOR DANEK, INC.KWP MNH MNI NKB00613994576484
TSRH® Spinal SystemX0209483MEDTRONIC SOFAMOR DANEK, INC.KWP MNH MNI NKB00613994576613
TSRH® Spinal SystemX0209508MEDTRONIC SOFAMOR DANEK, INC.KWP MNH MNI NKB00613994576767
TSRH® Spinal SystemX0209515MEDTRONIC SOFAMOR DANEK, INC.KWP MNH MNI NKB00613994576699
TSRH® Spinal System83545209HMEDTRONIC SOFAMOR DANEK, INC.KWP MNH MNI NKB00613994888143
TSRH® Spinal System83575309HMEDTRONIC SOFAMOR DANEK, INC.KWP MNH MNI NKB00613994887979
TSRH® Spinal SystemX0209493MEDTRONIC SOFAMOR DANEK, INC.KWP MNH MNI NKB00613994576514
TSRH® Spinal System83565309HMEDTRONIC SOFAMOR DANEK, INC.KWP MNH MNI NKB00613994888341
TSRH® Spinal SystemX0209482MEDTRONIC SOFAMOR DANEK, INC.KWP MNH MNI NKB00613994576620
TSRH® Spinal SystemX0209498MEDTRONIC SOFAMOR DANEK, INC.KWP MNH MNI NKB00613994576866
TSRH® Spinal SystemX0209481MEDTRONIC SOFAMOR DANEK, INC.KWP MNH MNI NKB00613994576637
TSRH® Spinal SystemX0209436MEDTRONIC SOFAMOR DANEK, INC.KWP MNH MNI NKB00613994577085
TSRH® Spinal SystemX0209488MEDTRONIC SOFAMOR DANEK, INC.KWP MNH MNI NKB00613994576569
TSRH® Spinal System83565409HMEDTRONIC SOFAMOR DANEK, INC.KWP MNH MNI NKB00613994888136