The following data is part of a premarket notification filed by Ortho Development Corp. with the FDA for Balanced Knee System High Flex Ps.
| Device ID | K123457 |
| 510k Number | K123457 |
| Device Name: | BALANCED KNEE SYSTEM HIGH FLEX PS |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | ORTHO DEVELOPMENT CORP. 12187 SOUTH BUSINESS PARK DR. Draper, UT 84020 |
| Contact | Tom Haueter |
| Correspondent | Tom Haueter ORTHO DEVELOPMENT CORP. 12187 SOUTH 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 | 2012-11-08 |
| Decision Date | 2013-03-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00822409006724 | K123457 | 000 |
| 00822409006601 | K123457 | 000 |
| 00822409006595 | K123457 | 000 |
| 00822409006588 | K123457 | 000 |
| 00822409006571 | K123457 | 000 |
| 00822409006564 | K123457 | 000 |
| 00822409006557 | K123457 | 000 |
| 00822409006540 | K123457 | 000 |
| 00822409006533 | K123457 | 000 |
| 00822409006526 | K123457 | 000 |
| 00822409006618 | K123457 | 000 |
| 00822409006625 | K123457 | 000 |
| 00822409006717 | K123457 | 000 |
| 00822409006700 | K123457 | 000 |
| 00822409006694 | K123457 | 000 |
| 00822409006687 | K123457 | 000 |
| 00822409006670 | K123457 | 000 |
| 00822409006663 | K123457 | 000 |
| 00822409006656 | K123457 | 000 |
| 00822409006649 | K123457 | 000 |
| 00822409006632 | K123457 | 000 |
| 00822409006519 | K123457 | 000 |