The following data is part of a premarket notification filed by Microport Orthopedics Inc. with the FDA for Profemur Renaissance Classic Long Neck Hip Stems.
| Device ID | K141235 |
| 510k Number | K141235 |
| Device Name: | PROFEMUR RENAISSANCE CLASSIC LONG NECK HIP STEMS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | MICROPORT ORTHOPEDICS INC. 5677 AIRLINE RD Arlington, TN 38002 |
| Contact | Byron Ledbetter |
| Correspondent | Byron Ledbetter MICROPORT ORTHOPEDICS INC. 5677 AIRLINE RD Arlington, TN 38002 |
| Product Code | LZO |
| Subsequent Product Code | JDI |
| Subsequent Product Code | LPH |
| Subsequent Product Code | MBL |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-13 |
| Decision Date | 2014-09-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00192629116481 | K141235 | 000 |
| M684PLLES0101 | K141235 | 000 |
| 00192629116306 | K141235 | 000 |
| 00192629116290 | K141235 | 000 |
| M684PLLSR0141 | K141235 | 000 |
| 00192629116276 | K141235 | 000 |
| 00192629116269 | K141235 | 000 |
| 00192629116252 | K141235 | 000 |
| M684PLLSR0101 | K141235 | 000 |
| M684PLLER0161 | K141235 | 000 |
| M684PLLER0151 | K141235 | 000 |
| M684PLLER0141 | K141235 | 000 |
| 00192629116207 | K141235 | 000 |
| M684PLLER0121 | K141235 | 000 |
| 00192629116184 | K141235 | 000 |
| 00192629116320 | K141235 | 000 |
| M684PLLES0121 | K141235 | 000 |
| 00192629116474 | K141235 | 000 |
| 00192629116467 | K141235 | 000 |
| M684PLLSS0151 | K141235 | 000 |
| 00192629116443 | K141235 | 000 |
| M684PLLSS0131 | K141235 | 000 |
| 00192629116429 | K141235 | 000 |
| 00192629116412 | K141235 | 000 |
| M684PLLSS0101 | K141235 | 000 |
| 00192629116399 | K141235 | 000 |
| M684PLLES0171 | K141235 | 000 |
| M684PLLES0161 | K141235 | 000 |
| M684PLLES0151 | K141235 | 000 |
| 00192629116351 | K141235 | 000 |
| 00192629116344 | K141235 | 000 |
| M684PLLER0101 | K141235 | 000 |