The following data is part of a premarket notification filed by Ortho Development Corporation with the FDA for Balanced Knee Revision System Trabecular Tibial Cone Augments.
| Device ID | K182085 |
| 510k Number | K182085 |
| Device Name: | Balanced Knee Revision System Trabecular Tibial Cone Augments |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | Ortho Development Corporation 12187 So. Business Park Drive Draper, UT 84020 |
| Contact | Adrienne Von Foller |
| Correspondent | Adrienne Von Foller Ortho Development Corporation 12187 So. Business Park Drive Draper, UT 84020 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-02 |
| Decision Date | 2018-10-31 |
| Summary: | summary |