The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Circular Fixation With Balanced Cable Transport.
| Device ID | K202762 |
| 510k Number | K202762 |
| Device Name: | Circular Fixation With Balanced Cable Transport |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | Smith & Nephew, Inc. 7135 Goodlett Farm Parkway Cordova, TN 38016 |
| Contact | Crystal Higgenbottom-shaffer |
| Correspondent | Crystal Higgenbottom-shaffer Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-21 |
| Decision Date | 2020-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556725252 | K202762 | 000 |
| 00885556725245 | K202762 | 000 |