The following data is part of a premarket notification filed by Ortho Development Corporation with the FDA for Alpine Cemented Hip System.
| Device ID | K153216 |
| 510k Number | K153216 |
| Device Name: | Alpine Cemented Hip System |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| 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 | JDI |
| Subsequent Product Code | KWL |
| Subsequent Product Code | KWY |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LZO |
| Subsequent Product Code | MBL |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-05 |
| Decision Date | 2016-02-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00822409037049 | K153216 | 000 |
| 00822409018833 | K153216 | 000 |
| 00822409018826 | K153216 | 000 |
| 00822409018819 | K153216 | 000 |
| 00822409018802 | K153216 | 000 |
| 00822409000456 | K153216 | 000 |
| 00822409000449 | K153216 | 000 |
| 00822409000432 | K153216 | 000 |
| 00822409000425 | K153216 | 000 |
| 00822409000418 | K153216 | 000 |
| 00822409000401 | K153216 | 000 |
| 00822409000395 | K153216 | 000 |
| 00822409000333 | K153216 | 000 |
| 00822409000326 | K153216 | 000 |
| 00822409000319 | K153216 | 000 |
| 00822409000302 | K153216 | 000 |
| 00822409000296 | K153216 | 000 |
| 00822409000289 | K153216 | 000 |
| 00822409018840 | K153216 | 000 |
| 00822409018857 | K153216 | 000 |
| 00822409018864 | K153216 | 000 |
| 00822409037032 | K153216 | 000 |
| 00822409037025 | K153216 | 000 |
| 00822409037018 | K153216 | 000 |
| 00822409037001 | K153216 | 000 |
| 00822409036998 | K153216 | 000 |
| 00822409036981 | K153216 | 000 |
| 00822409036875 | K153216 | 000 |
| 00822409036868 | K153216 | 000 |
| 00822409036851 | K153216 | 000 |
| 00822409036844 | K153216 | 000 |
| 00822409036837 | K153216 | 000 |
| 00822409036820 | K153216 | 000 |
| 00822409036813 | K153216 | 000 |
| 00822409018901 | K153216 | 000 |
| 00822409018895 | K153216 | 000 |
| 00822409018888 | K153216 | 000 |
| 00822409018871 | K153216 | 000 |
| 00822409000272 | K153216 | 000 |