The following data is part of a premarket notification filed by Ortho Development Corporation with the FDA for Legend Acetabular Liners.
| Device ID | K173951 |
| 510k Number | K173951 |
| Device Name: | Legend Acetabular Liners |
| 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 | 2017-12-27 |
| Decision Date | 2018-05-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00822409037360 | K173951 | 000 |
| 00822409037353 | K173951 | 000 |
| 00822409037285 | K173951 | 000 |
| 00822409037278 | K173951 | 000 |
| 00822409037186 | K173951 | 000 |
| 00822409037179 | K173951 | 000 |
| 00822409037063 | K173951 | 000 |
| 00822409037056 | K173951 | 000 |