The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Evos Small Fragment Plating System.
| Device ID | K170887 |
| 510k Number | K170887 |
| Device Name: | EVOS Small Fragment Plating System |
| Classification | Plate, Fixation, Bone |
| Applicant | Smith & Nephew, Inc. 1450 Brooks Road Memphis, TN 38116 |
| Contact | Samantha Staubach |
| Correspondent | Samantha Staubach Smith & Nephew, Inc. 1450 Brooks Road Memphis, TN 38116 |
| Product Code | HRS |
| Subsequent Product Code | HTN |
| Subsequent Product Code | HWC |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-27 |
| Decision Date | 2017-04-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556643594 | K170887 | 000 |
| 00885556770849 | K170887 | 000 |
| 00885556770856 | K170887 | 000 |
| 00885556770863 | K170887 | 000 |
| 00885556641699 | K170887 | 000 |
| 00885556641705 | K170887 | 000 |
| 00885556643563 | K170887 | 000 |
| 00885556643570 | K170887 | 000 |
| 00885556643587 | K170887 | 000 |
| 00885556770832 | K170887 | 000 |