The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Profix Total Knee System.
| Device ID | K030623 |
| 510k Number | K030623 |
| Device Name: | SMITH & NEPHEW PROFIX TOTAL KNEE SYSTEM |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Gino J Rouss |
| Correspondent | Gino J Rouss SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | MBH |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-27 |
| Decision Date | 2003-05-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556035078 | K030623 | 000 |
| 03596010484734 | K030623 | 000 |
| 03596010484727 | K030623 | 000 |
| 03596010484710 | K030623 | 000 |
| 03596010484703 | K030623 | 000 |
| 03596010484697 | K030623 | 000 |
| 03596010484680 | K030623 | 000 |
| 03596010484673 | K030623 | 000 |
| 03596010484666 | K030623 | 000 |
| 03596010484659 | K030623 | 000 |
| 03596010484642 | K030623 | 000 |
| 03596010484635 | K030623 | 000 |
| 03596010484628 | K030623 | 000 |
| 03596010484741 | K030623 | 000 |
| 03596010484758 | K030623 | 000 |
| 00885556034705 | K030623 | 000 |
| 00885556033876 | K030623 | 000 |
| 03596010484857 | K030623 | 000 |
| 03596010484840 | K030623 | 000 |
| 03596010484833 | K030623 | 000 |
| 03596010484826 | K030623 | 000 |
| 03596010484819 | K030623 | 000 |
| 03596010484802 | K030623 | 000 |
| 03596010484796 | K030623 | 000 |
| 03596010484789 | K030623 | 000 |
| 03596010484772 | K030623 | 000 |
| 03596010484765 | K030623 | 000 |
| 03596010219817 | K030623 | 000 |