Sofamor Danek USA,Inc.
FDA 510(k) & PMA Approved Devices — 41 products
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Total Devices41
Categories0
Latest FDA decision
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K991031 | COLORADO II SPINAL SYSTEM | MNH | 2000-05-10 | View |
| 510(k) | K984360 | COLORADO II SPINAL SYSTEM | MNH | 2000-03-30 | View |
| 510(k) | K992928 | CD HORIZON SPINAL SYSTEM | MNI | 1999-09-21 | View |
| 510(k) | K991036 | DANEK PLATE AND SCREW SYSTEM | MNH | 1999-09-14 | View |
| 510(k) | K991198 | DYNA-LOK PLUS SPINAL SYSTEM | KWP | 1999-08-27 | View |
| 510(k) | K991364 | MODIFICATION TO TENOR SPINAL SYSTEM-PLATES | MNH | 1999-05-19 | View |
| 510(k) | K981676 | CD HORIZON SPINAL SYSTEM | KWP | 1999-01-28 | View |
| 510(k) | K980184 | CD SPINAL SYSTEM | MNI | 1998-12-18 | View |
| 510(k) | K983672 | DYNA-LOK SPINAL SYSTEM | MNI | 1998-12-16 | View |
| 510(k) | K983706 | MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM | KWP | 1998-11-12 | View |
| 510(k) | K982990 | TSRH SPINAL SYSTEM | MNI | 1998-10-21 | View |
| 510(k) | K982490 | TENOR SPINAL SYSTEM | KWP | 1998-10-05 | View |
| 510(k) | K982686 | MODIFICATION TO TOWNLEY PEDICLE SCREW PLATING SYSTEM | MNI | 1998-08-07 | View |
| 510(k) | K963642 | INCL II ENDOSCOPE | GWG | 1998-03-18 | View |
| 510(k) | K973854 | ORION ANTERIOR CERVICAL PLATE SYSTEM | KWQ | 1998-03-16 | View |
| 510(k) | K974017 | TIMESH SYSTEM | HRS | 1998-01-16 | View |
| 510(k) | K973145 | TIMESH TITANIUM MINI-SOFTPLATE AND MICRO-SOFT PLATE/SCREW SYSTEM | JEY | 1997-11-19 | View |
| 510(k) | K964159 | CD SPINAL SYSTEM | KWP | 1997-10-16 | View |
| 510(k) | K963780 | DUAL ROD ANTERIOR FIXATOR SYSTEM | KWQ | 1997-07-30 | View |
| 510(k) | K970806 | ACPII ANTERIOR CERVICAL PLATE SYSTEM | KWQ | 1997-05-02 | View |
No matching devices.
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