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 | K172262 |
| 510k Number | K172262 |
| 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 East 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 | 2017-07-27 |
| Decision Date | 2017-08-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556908518 | K172262 | 000 |
| 00885556908501 | K172262 | 000 |
| 00885556908495 | K172262 | 000 |
| 00885556908488 | K172262 | 000 |
| 00885556908471 | K172262 | 000 |
| 00885556908464 | K172262 | 000 |
| 00885556908457 | K172262 | 000 |
| 00885556908440 | K172262 | 000 |