Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K152604
KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set · Medtronic Sofamor Danek USA, Incorporated · decided 2016-01-06 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| CD HORIZON® Fenestrated Screw Set | 55840029565T | MEDTRONIC SOFAMOR DANEK, INC. | MNI | 00643169679207 |
| CD HORIZON® Fenestrated Screw Set | 55840027565T | MEDTRONIC SOFAMOR DANEK, INC. | MNI | 00643169678989 |
| CD HORIZON® Fenestrated Screw Set | 54840024565T | MEDTRONIC SOFAMOR DANEK, INC. | MNI | 00643169678101 |
| CD HORIZON® Fenestrated Screw Set | 54840024560T | MEDTRONIC SOFAMOR DANEK, INC. | MNI | 00643169678095 |
| CD HORIZON® Fenestrated Screw Set | 55840026535T | MEDTRONIC SOFAMOR DANEK, INC. | MNI | 00643169678811 |
| CD HORIZON® Fenestrated Screw Set | 55840025565T | MEDTRONIC SOFAMOR DANEK, INC. | MNI | 00643169678767 |
| CD HORIZON® Fenestrated Screw Set | 54840027530T | MEDTRONIC SOFAMOR DANEK, INC. | MNI | 00643169678361 |
| CD HORIZON® Fenestrated Screw Set | 54840028555T | MEDTRONIC SOFAMOR DANEK, INC. | MNI | 00643169678521 |
| (unnamed) | 1850077 | MEDTRONIC SOFAMOR DANEK, INC. | MNI | 00613994404923 |
| CD HORIZON® Fenestrated Screw Set | 55840024550T | MEDTRONIC SOFAMOR DANEK, INC. | MNI | 00643169678620 |
| CD HORIZON® Fenestrated Screw Set | 54840026530T | MEDTRONIC SOFAMOR DANEK, INC. | MNI | 00643169678255 |
| CD HORIZON® Fenestrated Screw Set | 54840024535T | MEDTRONIC SOFAMOR DANEK, INC. | MNI | 00643169678040 |
| CD HORIZON® Fenestrated Screw Set | 55840027575T | MEDTRONIC SOFAMOR DANEK, INC. | MNI | 00643169679009 |
| CD HORIZON® Fenestrated Screw Set | 54840024530T | MEDTRONIC SOFAMOR DANEK, INC. | MNI | 00643169678033 |
| CD HORIZON® Fenestrated Screw Set | 55840028560T | MEDTRONIC SOFAMOR DANEK, INC. | MNI | 00643169679085 |
| CD HORIZON® Fenestrated Screw Set | 55840029575T | MEDTRONIC SOFAMOR DANEK, INC. | MNI | 00643169679221 |
| CD HORIZON® Fenestrated Screw Set | 54840024555T | MEDTRONIC SOFAMOR DANEK, INC. | MNI | 00643169678088 |
| CD HORIZON® Fenestrated Screw Set | 55840028580T | MEDTRONIC SOFAMOR DANEK, INC. | MNI | 00643169679122 |
| CD HORIZON® Fenestrated Screw Set | 55840024540T | MEDTRONIC SOFAMOR DANEK, INC. | MNI | 00643169678606 |
| CD HORIZON® Fenestrated Screw Set | 55840026570T | MEDTRONIC SOFAMOR DANEK, INC. | MNI | 00643169678880 |
| CD HORIZON® Fenestrated Screw Set | 55840029570T | MEDTRONIC SOFAMOR DANEK, INC. | MNI | 00643169679214 |
| CD HORIZON® Fenestrated Screw Set | 54840027570T | MEDTRONIC SOFAMOR DANEK, INC. | MNI | 00643169678446 |
| CD HORIZON® Fenestrated Screw Set | 55840027570T | MEDTRONIC SOFAMOR DANEK, INC. | MNI | 00643169678996 |
| CD HORIZON® Fenestrated Screw Set | 54840028580T | MEDTRONIC SOFAMOR DANEK, INC. | MNI | 00643169678576 |
| CD HORIZON® Fenestrated Screw Set | 54840024545T | MEDTRONIC SOFAMOR DANEK, INC. | MNI | 00643169678064 |