The following data is part of a premarket notification filed by Ortho Development Corp. with the FDA for Ovation 10/12 Hip Stem.
| Device ID | K131022 |
| 510k Number | K131022 |
| Device Name: | OVATION 10/12 HIP STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| 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 | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-12 |
| Decision Date | 2013-10-16 |
| Summary: | summary |