The following data is part of a premarket notification filed by Smith & Nephew, Inc with the FDA for Evos Small Fragment Upper Extremity Plates Line Additions.
| Device ID | K190253 |
| 510k Number | K190253 |
| Device Name: | EVOS Small Fragment Upper Extremity Plates Line Additions |
| Classification | Plate, Fixation, Bone |
| Applicant | Smith & Nephew, Inc 1450 Brooks Road Memphis, TN 38116 |
| Contact | Shereen Bienz |
| Correspondent | Shereen Bienz Smith & Nephew, Inc 1450 Brooks Road Memphis, TN 38116 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-07 |
| Decision Date | 2019-03-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556729090 | K190253 | 000 |
| 00885556726921 | K190253 | 000 |
| 00885556726891 | K190253 | 000 |
| 00885556726884 | K190253 | 000 |
| 00885556726877 | K190253 | 000 |
| 00885556726860 | K190253 | 000 |
| 00885556726853 | K190253 | 000 |
| 00885556726846 | K190253 | 000 |
| 00885556726839 | K190253 | 000 |
| 00885556726822 | K190253 | 000 |
| 00885556726815 | K190253 | 000 |
| 00885556726808 | K190253 | 000 |
| 00885556726792 | K190253 | 000 |
| 00885556726945 | K190253 | 000 |
| 00885556726952 | K190253 | 000 |
| 00885556729083 | K190253 | 000 |
| 00885556729052 | K190253 | 000 |
| 00885556729045 | K190253 | 000 |
| 00885556729038 | K190253 | 000 |
| 00885556729021 | K190253 | 000 |
| 00885556727034 | K190253 | 000 |
| 00885556727027 | K190253 | 000 |
| 00885556727010 | K190253 | 000 |
| 00885556727003 | K190253 | 000 |
| 00885556726990 | K190253 | 000 |
| 00885556726983 | K190253 | 000 |
| 00885556726969 | K190253 | 000 |
| 00885556726785 | K190253 | 000 |