The following data is part of a premarket notification filed by Orthosoft, Inc. with the FDA for Cas Psi Knee System.
| Device ID | K131409 |
| 510k Number | K131409 |
| Device Name: | CAS PSI KNEE SYSTEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | ORTHOSOFT, INC. 75 QUEEN ST., SUITE 3300 Montreal, Quebec, CA H3c 2n6 |
| Contact | Christopher Mclean |
| Correspondent | Christopher Mclean ORTHOSOFT, INC. 75 QUEEN ST., SUITE 3300 Montreal, Quebec, CA H3c 2n6 |
| Product Code | JWH |
| Subsequent Product Code | MBH |
| Subsequent Product Code | OOG |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-15 |
| Decision Date | 2013-09-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024304116 | K131409 | 000 |
| 00889024305663 | K131409 | 000 |
| 00889024305656 | K131409 | 000 |
| 00889024305649 | K131409 | 000 |
| 00889024305632 | K131409 | 000 |
| 00889024305625 | K131409 | 000 |
| 00889024305618 | K131409 | 000 |
| 00889024305601 | K131409 | 000 |
| 00889024305595 | K131409 | 000 |
| 00889024305588 | K131409 | 000 |
| 00889024305571 | K131409 | 000 |
| 00889024305564 | K131409 | 000 |
| 00889024211629 | K131409 | 000 |
| 00889024305670 | K131409 | 000 |
| 00889024305687 | K131409 | 000 |
| 00889024305694 | K131409 | 000 |
| 00889024304109 | K131409 | 000 |
| 00889024304093 | K131409 | 000 |
| 00889024304086 | K131409 | 000 |
| 00889024305786 | K131409 | 000 |
| 00889024305779 | K131409 | 000 |
| 00889024305762 | K131409 | 000 |
| 00889024305755 | K131409 | 000 |
| 00889024305748 | K131409 | 000 |
| 00889024305731 | K131409 | 000 |
| 00889024305724 | K131409 | 000 |
| 00889024305717 | K131409 | 000 |
| 00889024305700 | K131409 | 000 |
| 00887868557606 | K131409 | 000 |