The following data is part of a premarket notification filed by Arthrex Inc. with the FDA for Arthrex Knee Systems.
| Device ID | K171365 |
| 510k Number | K171365 |
| Device Name: | Arthrex Knee Systems |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | Arthrex Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
| Contact | David L. Rogers |
| Correspondent | David L. Rogers Arthrex Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
| Product Code | MBH |
| Subsequent Product Code | HSX |
| Subsequent Product Code | KRR |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-09 |
| Decision Date | 2017-11-07 |
| Summary: | summary |