The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Porous Patella And Porous Tibia Baseplate.
| Device ID | K211221 |
| 510k Number | K211221 |
| Device Name: | Porous Patella And Porous Tibia Baseplate |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Contact | Brad Sheals |
| Correspondent | Brad Sheals Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Product Code | MBH |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-23 |
| Decision Date | 2021-10-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556721841 | K211221 | 000 |
| 00885556721971 | K211221 | 000 |
| 00885556721988 | K211221 | 000 |
| 00885556722572 | K211221 | 000 |
| 00885556732946 | K211221 | 000 |
| 00885556769546 | K211221 | 000 |
| 00885556769843 | K211221 | 000 |
| 00885556732953 | K211221 | 000 |
| 00885556732960 | K211221 | 000 |
| 00885556721964 | K211221 | 000 |
| 00885556721957 | K211221 | 000 |
| 00885556721940 | K211221 | 000 |
| 00885556721858 | K211221 | 000 |
| 00885556721872 | K211221 | 000 |
| 00885556721889 | K211221 | 000 |
| 00885556721896 | K211221 | 000 |
| 00885556721902 | K211221 | 000 |
| 00885556721919 | K211221 | 000 |
| 00885556721926 | K211221 | 000 |
| 00885556721933 | K211221 | 000 |
| 00885556732977 | K211221 | 000 |
| 00885556732984 | K211221 | 000 |
| 00885556769522 | K211221 | 000 |
| 00885556769539 | K211221 | 000 |
| 00885556769553 | K211221 | 000 |
| 00885556769560 | K211221 | 000 |
| 00885556769577 | K211221 | 000 |
| 00885556769829 | K211221 | 000 |
| 00885556769836 | K211221 | 000 |
| 00885556769850 | K211221 | 000 |
| 00885556733097 | K211221 | 000 |
| 00885556733080 | K211221 | 000 |
| 00885556733073 | K211221 | 000 |
| 00885556732991 | K211221 | 000 |
| 00885556733004 | K211221 | 000 |
| 00885556733011 | K211221 | 000 |
| 00885556733028 | K211221 | 000 |
| 00885556733035 | K211221 | 000 |
| 00885556733042 | K211221 | 000 |
| 00885556733059 | K211221 | 000 |
| 00885556733066 | K211221 | 000 |
| 00885556769867 | K211221 | 000 |