The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Maverick External Fixation System.
| Device ID | K213874 |
| 510k Number | K213874 |
| Device Name: | MAVERICK External Fixation System |
| Classification | Pin, Fixation, Threaded |
| Applicant | Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Contact | Brad Sheals |
| Correspondent | Brad Sheals Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Product Code | JDW |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-13 |
| Decision Date | 2022-02-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556798553 | K213874 | 000 |
| 00885556798867 | K213874 | 000 |
| 00885556798850 | K213874 | 000 |
| 00885556798843 | K213874 | 000 |
| 00885556798836 | K213874 | 000 |
| 00885556798942 | K213874 | 000 |
| 00885556798935 | K213874 | 000 |
| 00885556798928 | K213874 | 000 |
| 00885556798911 | K213874 | 000 |
| 00885556798904 | K213874 | 000 |
| 00885556798898 | K213874 | 000 |
| 00885556798881 | K213874 | 000 |
| 00885556798874 | K213874 | 000 |
| 00885556798775 | K213874 | 000 |
| 00885556798645 | K213874 | 000 |
| 00885556798782 | K213874 | 000 |
| 00885556798799 | K213874 | 000 |
| 00885556798560 | K213874 | 000 |
| 00885556799222 | K213874 | 000 |
| 00885556798768 | K213874 | 000 |
| 00885556798751 | K213874 | 000 |
| 00885556798744 | K213874 | 000 |
| 00885556798737 | K213874 | 000 |
| 00885556798720 | K213874 | 000 |
| 00885556798614 | K213874 | 000 |
| 00885556798607 | K213874 | 000 |
| 00885556798591 | K213874 | 000 |
| 00885556802434 | K213874 | 000 |
| 00885556798829 | K213874 | 000 |
| 00885556798812 | K213874 | 000 |
| 00885556798805 | K213874 | 000 |
| 00885556798638 | K213874 | 000 |