The following data is part of a premarket notification filed by Ortho Development with the FDA for Alpine Hip Stem; Alpine Ha Hip Stem.
| Device ID | K141001 |
| 510k Number | K141001 |
| Device Name: | ALPINE HIP STEM; ALPINE HA HIP STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | ORTHO DEVELOPMENT 12187 S. BUSINESS PARK DR. Draper, UT 84020 |
| Contact | Mike Ensign |
| Correspondent | Mike Ensign ORTHO DEVELOPMENT 12187 S. BUSINESS PARK DR. Draper, UT 84020 |
| Product Code | LPH |
| Subsequent Product Code | KWL |
| Subsequent Product Code | KWY |
| Subsequent Product Code | LZO |
| Subsequent Product Code | MBL |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-18 |
| Decision Date | 2014-07-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00822409000258 | K141001 | 000 |
| 00822409000111 | K141001 | 000 |
| 00822409000104 | K141001 | 000 |
| 00822409000098 | K141001 | 000 |
| 00822409000081 | K141001 | 000 |
| 00822409000074 | K141001 | 000 |
| 00822409000067 | K141001 | 000 |
| 00822409000050 | K141001 | 000 |
| 00822409000043 | K141001 | 000 |
| 00822409000036 | K141001 | 000 |
| 00822409000029 | K141001 | 000 |
| 00822409000128 | K141001 | 000 |
| 00822409000142 | K141001 | 000 |
| 00822409000241 | K141001 | 000 |
| 00822409000234 | K141001 | 000 |
| 00822409000227 | K141001 | 000 |
| 00822409000210 | K141001 | 000 |
| 00822409000203 | K141001 | 000 |
| 00822409000197 | K141001 | 000 |
| 00822409000180 | K141001 | 000 |
| 00822409000173 | K141001 | 000 |
| 00822409000166 | K141001 | 000 |
| 00822409000159 | K141001 | 000 |
| 00822409000012 | K141001 | 000 |