The following data is part of a premarket notification filed by Ortho Development Corp. with the FDA for Encompass 10*17 And 12*17 Extended Press-fit Hip Stems.
| Device ID | K053293 |
| 510k Number | K053293 |
| Device Name: | ENCOMPASS 10*17 AND 12*17 EXTENDED PRESS-FIT HIP STEMS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | ORTHO DEVELOPMENT CORP. 12187 SOUTH BUSINESS PARK DR. Draper, UT 84020 |
| Contact | William J Griffin |
| Correspondent | William J Griffin 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 | 2005-11-25 |
| Decision Date | 2006-02-16 |