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

Clearance record K133653

ANATOMIC PEEK PTC CERVICAL FUSION SYSTEM · Medtronic Sofamor Danek USA, Inc. · decided 2014-04-28 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
ANATOMIC PEEK PTC Cervical Fusion System5030341MEDTRONIC SOFAMOR DANEK, INC.ODP00643169357686
ANATOMIC PEEK PTC Cervical Fusion SystemX1013038MEDTRONIC SOFAMOR DANEK, INC.ODP00643169411890
ANATOMIC PEEK PTC Cervical Fusion SystemX1013040MEDTRONIC SOFAMOR DANEK, INC.ODP00643169411913
ANATOMIC PEEK PTC Cervical Fusion System5030841MEDTRONIC SOFAMOR DANEK, INC.ODP00643169357495
ANATOMIC PEEK PTC Cervical Fusion System5030641MEDTRONIC SOFAMOR DANEK, INC.ODP00643169357556
ANATOMIC PEEK PTC Cervical Fusion System5030664MEDTRONIC SOFAMOR DANEK, INC.ODP00643169357549
ANATOMIC PEEK PTC Cervical Fusion System5030764MEDTRONIC SOFAMOR DANEK, INC.ODP00643169357518
ANATOMIC PEEK PTC Cervical Fusion SystemX1013036MEDTRONIC SOFAMOR DANEK, INC.ODP00643169411876
ANATOMIC PEEK PTC Cervical Fusion SystemX1013047MEDTRONIC SOFAMOR DANEK, INC.ODP00643169411982
ANATOMIC PEEK PTC Cervical Fusion SystemX1013049MEDTRONIC SOFAMOR DANEK, INC.ODP00643169412002
ANATOMIC PEEK PTC Cervical Fusion System5030386MEDTRONIC SOFAMOR DANEK, INC.ODP00643169408036
ANATOMIC PEEK PTC Cervical Fusion SystemX1013043MEDTRONIC SOFAMOR DANEK, INC.ODP00643169411944
ANATOMIC PEEK PTC Cervical Fusion System5030941MEDTRONIC SOFAMOR DANEK, INC.ODP00643169357464
ANATOMIC PEEK PTC Cervical Fusion SystemX1013037MEDTRONIC SOFAMOR DANEK, INC.ODP00643169411883
ANATOMIC PEEK PTC Cervical Fusion System5030741MEDTRONIC SOFAMOR DANEK, INC.ODP00643169357525
ANATOMIC PEEK PTC Cervical Fusion System5030141MEDTRONIC SOFAMOR DANEK, INC.ODP00643169357624
ANATOMIC PEEK PTC Cervical Fusion System5030564MEDTRONIC SOFAMOR DANEK, INC.ODP00643169357570
ANATOMIC PEEK PTC Cervical Fusion SystemX1013044MEDTRONIC SOFAMOR DANEK, INC.ODP00643169411951
ANATOMIC PEEK PTC Cervical Fusion System5030441MEDTRONIC SOFAMOR DANEK, INC.ODP00643169357709
ANATOMIC PEEK PTC Cervical Fusion SystemX1013046MEDTRONIC SOFAMOR DANEK, INC.ODP00643169411975
ANATOMIC PEEK PTC Cervical Fusion SystemX1013042MEDTRONIC SOFAMOR DANEK, INC.ODP00643169411937
ANATOMIC PEEK PTC Cervical Fusion SystemX1013041MEDTRONIC SOFAMOR DANEK, INC.ODP00643169411920
ANATOMIC PEEK PTC Cervical Fusion System5030241MEDTRONIC SOFAMOR DANEK, INC.ODP00643169357655
ANATOMIC PEEK PTC Cervical Fusion SystemX1013035MEDTRONIC SOFAMOR DANEK, INC.ODP00643169411869
ANATOMIC PEEK PTC Cervical Fusion System5030541MEDTRONIC SOFAMOR DANEK, INC.ODP00643169357587