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

Clearance record K152277

PIVOX(tm) Oblique Lateral Spinal System · Medtronic Sofamor Danek USA, Inc. · decided 2015-11-13 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
PIVOX™ Oblique Lateral Spinal System2131360MEDTRONIC SOFAMOR DANEK, INC.KWQ MAX OVD00643169605022
PIVOX™ Oblique Lateral Spinal System2131240MEDTRONIC SOFAMOR DANEK, INC.KWQ MAX OVD00643169604933
PIVOX™ Oblique Lateral Spinal System2190240MEDTRONIC SOFAMOR DANEK, INC.KWQ MAX OVD00643169598935
PIVOX™ Oblique Lateral Spinal System2110260MEDTRONIC SOFAMOR DANEK, INC.KWQ MAX OVD00643169601239
PIVOX™ Oblique Lateral Spinal System2172355MEDTRONIC SOFAMOR DANEK, INC.KWQ MAX OVD00643169595439
PIVOX™ Oblique Lateral Spinal System2172245MEDTRONIC SOFAMOR DANEK, INC.KWQ MAX OVD00643169595408
PIVOX™ Oblique Lateral Spinal System2130540MEDTRONIC SOFAMOR DANEK, INC.KWQ MAX OVD00643169604889
PIVOX™ Oblique Lateral Spinal System2130350MEDTRONIC SOFAMOR DANEK, INC.KWQ MAX OVD00643169604803
PIVOX™ Oblique Lateral Spinal System2173360MEDTRONIC SOFAMOR DANEK, INC.KWQ MAX OVD00643169600041
PIVOX™ Oblique Lateral Spinal System2191350MEDTRONIC SOFAMOR DANEK, INC.KWQ MAX OVD00643169599178
PIVOX™ Oblique Lateral Spinal System2190455MEDTRONIC SOFAMOR DANEK, INC.KWQ MAX OVD00643169599062
PIVOX™ Oblique Lateral Spinal System2122640MEDTRONIC SOFAMOR DANEK, INC.KWQ MAX OVD00643169606470
PIVOX™ Oblique Lateral Spinal System2111445MEDTRONIC SOFAMOR DANEK, INC.KWQ MAX OVD00643169601550
PIVOX™ Oblique Lateral Spinal System2173560MEDTRONIC SOFAMOR DANEK, INC.KWQ MAX OVD00643169600140
PIVOX™ Oblique Lateral Spinal System2173540MEDTRONIC SOFAMOR DANEK, INC.KWQ MAX OVD00643169600102
PIVOX™ Oblique Lateral Spinal System2172640MEDTRONIC SOFAMOR DANEK, INC.KWQ MAX OVD00643169596184
PIVOX™ Oblique Lateral Spinal System2172655MEDTRONIC SOFAMOR DANEK, INC.KWQ MAX OVD00763000878467
PIVOX™ Oblique Lateral Spinal System2140020MEDTRONIC SOFAMOR DANEK, INC.KWQ MAX OVD00643169639553
PIVOX™ Oblique Lateral Spinal System2190540MEDTRONIC SOFAMOR DANEK, INC.KWQ MAX OVD00643169599086
PIVOX™ Oblique Lateral Spinal System2191245MEDTRONIC SOFAMOR DANEK, INC.KWQ MAX OVD00643169595507
PIVOX™ Oblique Lateral Spinal System2171440MEDTRONIC SOFAMOR DANEK, INC.KWQ MAX OVD00643169596009
PIVOX™ Oblique Lateral Spinal System2172445MEDTRONIC SOFAMOR DANEK, INC.KWQ MAX OVD00763000878412
PIVOX™ Oblique Lateral Spinal System2143001MEDTRONIC SOFAMOR DANEK, INC.KWQ MAX OVD00643169639577
PIVOX™ Oblique Lateral Spinal System2191455MEDTRONIC SOFAMOR DANEK, INC.KWQ MAX OVD00643169595552
PIVOX™ Oblique Lateral Spinal System2173455MEDTRONIC SOFAMOR DANEK, INC.KWQ MAX OVD00763000878504