The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Acute Qc Strut And Components.
| Device ID | K221792 |
| 510k Number | K221792 |
| Device Name: | Acute QC Strut And Components |
| Classification | Software For Diagnosis/treatment |
| Applicant | Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Contact | Amanda Lammey |
| Correspondent | Amanda Lammey Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Product Code | OSN |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-21 |
| Decision Date | 2022-08-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556807064 | K221792 | 000 |
| 00885556807057 | K221792 | 000 |
| 20885556807129 | K221792 | 000 |
| 20885556807112 | K221792 | 000 |
| 20885556807105 | K221792 | 000 |
| 20885556807099 | K221792 | 000 |
| 00885556807088 | K221792 | 000 |
| 00885556807071 | K221792 | 000 |