The following data is part of a premarket notification filed by Ortho Development Corp. with the FDA for Encompass Cemented Hip Stem & 10/12 Cobalt-chrome Femoral Heads.
| Device ID | K050637 |
| 510k Number | K050637 |
| Device Name: | ENCOMPASS CEMENTED HIP STEM & 10/12 COBALT-CHROME FEMORAL HEADS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| 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 | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-11 |
| Decision Date | 2005-09-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00822409012015 | K050637 | 000 |
| 00822409011858 | K050637 | 000 |
| 00822409011865 | K050637 | 000 |
| 00822409011872 | K050637 | 000 |
| 00822409011889 | K050637 | 000 |
| 00822409011896 | K050637 | 000 |
| 00822409011902 | K050637 | 000 |
| 00822409011919 | K050637 | 000 |
| 00822409011926 | K050637 | 000 |
| 00822409011933 | K050637 | 000 |
| 00822409011940 | K050637 | 000 |
| 00822409011957 | K050637 | 000 |
| 00822409011964 | K050637 | 000 |
| 00822409011971 | K050637 | 000 |
| 00822409011988 | K050637 | 000 |
| 00822409011995 | K050637 | 000 |
| 00822409012008 | K050637 | 000 |
| 00822409011841 | K050637 | 000 |