Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K162153
Integra® CAPTURE Screw System & Integra® Ti6® Internal Fixation System · Ascension Orthopedics · decided 2017-07-14 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Ti6 Internal Fixation System | DS2030 | Smith & Nephew, Inc. | HWC | 00885556835074 |
| Capture Screw System | AD2044 | Smith & Nephew, Inc. | HWC | 00885556823927 |
| Capture Screw System | AQ2012 | Smith & Nephew, Inc. | HWC | 00885556824405 |
| Capture Screw System | AQ2712 | Smith & Nephew, Inc. | HWC | 00885556824436 |
| Capture Screw System | AD2040 | Smith & Nephew, Inc. | HWC | 00885556823903 |
| Capture Screw System | AD2038 | Smith & Nephew, Inc. | HWC | 00885556823897 |
| Ti6 Internal Fixation System | DS2034 | Smith & Nephew, Inc. | HWC | 00885556835098 |
| Capture Screw System | AQ2718 | Smith & Nephew, Inc. | HWC | 00885556824467 |
| Ti6 Internal Fixation System | DS2042 | Smith & Nephew, Inc. | HWC | 00885556835135 |
| Capture Screw System | AQ2722 | Smith & Nephew, Inc. | HWC | 00885556824481 |
| Ti6 Internal Fixation System | DS2032 | Smith & Nephew, Inc. | HWC | 00885556835081 |
| Capture Screw System | AQ2011 | Smith & Nephew, Inc. | HWC | 00885556824399 |
| Ti6 Internal Fixation System | DS2040 | Smith & Nephew, Inc. | HWC | 00885556835128 |
| Ti6 Internal Fixation System | TQ2718 | Smith & Nephew, Inc. | HWC | 00885556836361 |
| Ti6 Internal Fixation System | DS2046 | Smith & Nephew, Inc. | HWC | 00885556835159 |
| Capture Screw System | AD2034 | Smith & Nephew, Inc. | HWC | 00885556823873 |
| Ti6 Internal Fixation System | DS2036 | Smith & Nephew, Inc. | HWC | 00885556835104 |
| Capture Screw System | AD2050 | Smith & Nephew, Inc. | HWC | 00885556823958 |
| Capture Screw System | AQ2714 | Smith & Nephew, Inc. | HWC | 00885556824443 |
| Ti6 Internal Fixation System | TQ2722 | Smith & Nephew, Inc. | HWC | 00885556836385 |
| Capture Screw System | AD2026 | Smith & Nephew, Inc. | HWC | 00885556823835 |
| Capture Screw System | AD2032 | Smith & Nephew, Inc. | HWC | 00885556823866 |
| Capture Screw System | AQ2720 | Smith & Nephew, Inc. | HWC | 00885556824474 |
| Ti6 Internal Fixation System | TQ2714 | Smith & Nephew, Inc. | HWC | 00885556836347 |
| Ti6 Internal Fixation System | TQ2712 | Smith & Nephew, Inc. | HWC | 00885556836330 |