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)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| ANATOMIC PEEK PTC Cervical Fusion System | 5030341 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00643169357686 |
| ANATOMIC PEEK PTC Cervical Fusion System | X1013038 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00643169411890 |
| ANATOMIC PEEK PTC Cervical Fusion System | X1013040 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00643169411913 |
| ANATOMIC PEEK PTC Cervical Fusion System | 5030841 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00643169357495 |
| ANATOMIC PEEK PTC Cervical Fusion System | 5030641 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00643169357556 |
| ANATOMIC PEEK PTC Cervical Fusion System | 5030664 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00643169357549 |
| ANATOMIC PEEK PTC Cervical Fusion System | 5030764 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00643169357518 |
| ANATOMIC PEEK PTC Cervical Fusion System | X1013036 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00643169411876 |
| ANATOMIC PEEK PTC Cervical Fusion System | X1013047 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00643169411982 |
| ANATOMIC PEEK PTC Cervical Fusion System | X1013049 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00643169412002 |
| ANATOMIC PEEK PTC Cervical Fusion System | 5030386 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00643169408036 |
| ANATOMIC PEEK PTC Cervical Fusion System | X1013043 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00643169411944 |
| ANATOMIC PEEK PTC Cervical Fusion System | 5030941 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00643169357464 |
| ANATOMIC PEEK PTC Cervical Fusion System | X1013037 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00643169411883 |
| ANATOMIC PEEK PTC Cervical Fusion System | 5030741 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00643169357525 |
| ANATOMIC PEEK PTC Cervical Fusion System | 5030141 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00643169357624 |
| ANATOMIC PEEK PTC Cervical Fusion System | 5030564 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00643169357570 |
| ANATOMIC PEEK PTC Cervical Fusion System | X1013044 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00643169411951 |
| ANATOMIC PEEK PTC Cervical Fusion System | 5030441 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00643169357709 |
| ANATOMIC PEEK PTC Cervical Fusion System | X1013046 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00643169411975 |
| ANATOMIC PEEK PTC Cervical Fusion System | X1013042 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00643169411937 |
| ANATOMIC PEEK PTC Cervical Fusion System | X1013041 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00643169411920 |
| ANATOMIC PEEK PTC Cervical Fusion System | 5030241 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00643169357655 |
| ANATOMIC PEEK PTC Cervical Fusion System | X1013035 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00643169411869 |
| ANATOMIC PEEK PTC Cervical Fusion System | 5030541 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00643169357587 |