The following data is part of a premarket notification filed by Ortho Development Corporation with the FDA for Balanced Knee Revision System - Offset Junction Box.
| Device ID | K180743 |
| 510k Number | K180743 |
| Device Name: | Balanced Knee Revision System - Offset Junction Box |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | Ortho Development Corporation 12187 So. Business Park Drive Draper, UT 84020 |
| Contact | Dan Petersen |
| Correspondent | Dan Petersen 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 | 2018-03-22 |
| Decision Date | 2018-06-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00822409037841 | K180743 | 000 |
| 00822409037834 | K180743 | 000 |
| 00822409037810 | K180743 | 000 |
| 00822409037803 | K180743 | 000 |