The following data is part of a premarket notification filed by Ortho Development with the FDA for Balanced Knee System Revision Offset Tibia.
| Device ID | K103837 |
| 510k Number | K103837 |
| Device Name: | BALANCED KNEE SYSTEM REVISION OFFSET TIBIA |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | ORTHO DEVELOPMENT 12187 S. BUSINESS PARK DR. Draper, UT 84020 |
| Contact | Tom Haueter |
| Correspondent | Tom Haueter ORTHO DEVELOPMENT 12187 S. BUSINESS PARK DR. 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 | 2010-12-30 |
| Decision Date | 2011-03-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00822409006502 | K103837 | 000 |
| 00822409006410 | K103837 | 000 |
| 00822409006427 | K103837 | 000 |
| 00822409006434 | K103837 | 000 |
| 00822409006441 | K103837 | 000 |
| 00822409006458 | K103837 | 000 |
| 00822409006465 | K103837 | 000 |
| 00822409006472 | K103837 | 000 |
| 00822409006489 | K103837 | 000 |
| 00822409006496 | K103837 | 000 |
| 00822409006403 | K103837 | 000 |