The following data is part of a premarket notification filed by Ortho Development Corporation with the FDA for Escalade Legend Acetabular Shell.
| Device ID | K161080 |
| 510k Number | K161080 |
| Device Name: | Escalade Legend Acetabular Shell |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | ORTHO DEVELOPMENT CORPORATION 12187 SOUTH BUSINESS PARK DRIVE Draper, UT 84020 |
| Contact | Drew Weaver |
| Correspondent | Drew Weaver ORTHO DEVELOPMENT CORPORATION 12187 SOUTH BUSINESS PARK DRIVE Draper, UT 84020 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-18 |
| Decision Date | 2016-05-17 |
| Summary: | summary |