The following data is part of a premarket notification filed by Orthosoft Inc. (d/b/a Zimmer Cas) with the FDA for X-psi Knee System.
| Device ID | K171269 |
| 510k Number | K171269 |
| Device Name: | X-PSI Knee System |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | Orthosoft Inc. (d/b/a Zimmer CAS) 75 Queen Street Suite 3300 Montreal, CA H3c 2n6 |
| Contact | Guylaine Roy |
| Correspondent | Paul Hardy Orthosoft Inc. (d/b/a Zimmer CAS) 75 Queen Street Suite 3300 Montreal, CA H3c 2n6 |
| Product Code | JWH |
| Subsequent Product Code | LLZ |
| 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 | 2017-05-01 |
| Decision Date | 2017-12-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024486782 | K171269 | 000 |
| 00889024486577 | K171269 | 000 |
| 00889024486584 | K171269 | 000 |
| 00889024486591 | K171269 | 000 |
| 00889024486607 | K171269 | 000 |
| 00889024486614 | K171269 | 000 |
| 00889024486621 | K171269 | 000 |
| 00889024486638 | K171269 | 000 |
| 00889024486706 | K171269 | 000 |
| 00889024486713 | K171269 | 000 |
| 00889024486720 | K171269 | 000 |
| 00889024486737 | K171269 | 000 |
| 00889024486744 | K171269 | 000 |
| 00889024486751 | K171269 | 000 |
| 00889024486768 | K171269 | 000 |
| 00889024486775 | K171269 | 000 |
| 00887868557590 | K171269 | 000 |