The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Profix Conforming Plus Tibial Insert.
| Device ID | K946236 |
| 510k Number | K946236 |
| Device Name: | PROFIX CONFORMING PLUS TIBIAL INSERT |
| Classification | Prosthesis, Toe, Constrained, Polymer |
| Applicant | SMITH & NEPHEW RICHARDS, INC. 1450 E. BROOKS RD. Memphis, TN 38116 |
| Contact | Thomas L Craig |
| Correspondent | Thomas L Craig SMITH & NEPHEW RICHARDS, INC. 1450 E. BROOKS RD. Memphis, TN 38116 |
| Product Code | KWH |
| CFR Regulation Number | 888.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-22 |
| Decision Date | 1995-07-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556416785 | K946236 | 000 |
| 00885556415931 | K946236 | 000 |
| 00885556415887 | K946236 | 000 |
| 00885556415832 | K946236 | 000 |
| 00885556415788 | K946236 | 000 |
| 00885556415733 | K946236 | 000 |
| 00885556415689 | K946236 | 000 |
| 00885556415634 | K946236 | 000 |
| 00885556415580 | K946236 | 000 |
| 00885556415535 | K946236 | 000 |
| 00885556415481 | K946236 | 000 |
| 00885556415436 | K946236 | 000 |
| 00885556415382 | K946236 | 000 |
| 00885556415337 | K946236 | 000 |
| 00885556415283 | K946236 | 000 |
| 00885556415986 | K946236 | 000 |
| 00885556416037 | K946236 | 000 |
| 00885556416730 | K946236 | 000 |
| 00885556416686 | K946236 | 000 |
| 00885556416631 | K946236 | 000 |
| 00885556416587 | K946236 | 000 |
| 00885556416532 | K946236 | 000 |
| 00885556416488 | K946236 | 000 |
| 00885556416433 | K946236 | 000 |
| 00885556416389 | K946236 | 000 |
| 00885556416334 | K946236 | 000 |
| 00885556416280 | K946236 | 000 |
| 00885556416235 | K946236 | 000 |
| 00885556416181 | K946236 | 000 |
| 00885556416136 | K946236 | 000 |
| 00885556416082 | K946236 | 000 |
| 00885556415238 | K946236 | 000 |