The following data is part of a premarket notification filed by Ortho Development Corp. with the FDA for Encompass Hip Stem, Tri-plus Acetabular Shell, Tri-plus Dcm Liner.
| Device ID | K042565 |
| 510k Number | K042565 |
| Device Name: | ENCOMPASS HIP STEM, TRI-PLUS ACETABULAR SHELL, TRI-PLUS DCM LINER |
| 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 | 2004-09-21 |
| Decision Date | 2005-04-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00822409016495 | K042565 | 000 |
| 00822409016310 | K042565 | 000 |
| 00822409016303 | K042565 | 000 |
| 00822409016297 | K042565 | 000 |
| 00822409016280 | K042565 | 000 |
| 00822409016273 | K042565 | 000 |
| 00822409016266 | K042565 | 000 |
| 00822409016259 | K042565 | 000 |
| 00822409016242 | K042565 | 000 |
| 00822409016235 | K042565 | 000 |
| 00822409016228 | K042565 | 000 |
| 00822409016211 | K042565 | 000 |
| 00822409016204 | K042565 | 000 |
| 00822409016198 | K042565 | 000 |
| 00822409016181 | K042565 | 000 |
| 00822409016327 | K042565 | 000 |
| 00822409016334 | K042565 | 000 |
| 00822409016341 | K042565 | 000 |
| 00822409016488 | K042565 | 000 |
| 00822409016471 | K042565 | 000 |
| 00822409016464 | K042565 | 000 |
| 00822409016457 | K042565 | 000 |
| 00822409016440 | K042565 | 000 |
| 00822409016433 | K042565 | 000 |
| 00822409016426 | K042565 | 000 |
| 00822409016419 | K042565 | 000 |
| 00822409016402 | K042565 | 000 |
| 00822409016396 | K042565 | 000 |
| 00822409016389 | K042565 | 000 |
| 00822409016372 | K042565 | 000 |
| 00822409016365 | K042565 | 000 |
| 00822409016358 | K042565 | 000 |
| 00822409016174 | K042565 | 000 |