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

Clearance record K103731

CAPSTONE R SPINAL SYSTEM · Medtronic Sofamor Danek · decided 2011-07-18 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
(unnamed)X1117023MEDTRONIC SOFAMOR DANEK, INC.MAX MQP00763000096885
(unnamed)X1117015MEDTRONIC SOFAMOR DANEK, INC.MAX MQP00763000096892
(unnamed)X1117017MEDTRONIC SOFAMOR DANEK, INC.MAX MQP00763000096915
(unnamed)X1117016MEDTRONIC SOFAMOR DANEK, INC.MAX MQP00763000096908
(unnamed)X1117022MEDTRONIC SOFAMOR DANEK, INC.MAX MQP00763000096878
Medtronic Reusable Instruments2990001MEDTRONIC SOFAMOR DANEK, INC.MAX00613994803061
Reprocessing Instructions for the Capstone Inserter2990003MEDTRONIC SOFAMOR DANEK, INC.MAX00613994846266