The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Maverick Mini External Fixation System.
| Device ID | K223112 |
| 510k Number | K223112 |
| Device Name: | MAVERICK Mini External Fixation System |
| Classification | Pin, Fixation, Threaded |
| Applicant | Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Contact | Allison Francis |
| Correspondent | Allison Francis 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 | 2022-10-03 |
| Decision Date | 2022-12-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556870105 | K223112 | 000 |
| 00885556870150 | K223112 | 000 |
| 00885556870112 | K223112 | 000 |
| 00885556870181 | K223112 | 000 |
| 00885556870174 | K223112 | 000 |
| 00885556870143 | K223112 | 000 |
| 00885556870136 | K223112 | 000 |
| 00885556870167 | K223112 | 000 |