The following data is part of a premarket notification filed by Microport Orthopedics Inc. with the FDA for Profemur Preserve Classic Stem.
| Device ID | K150302 |
| 510k Number | K150302 |
| Device Name: | PROFEMUR Preserve Classic Stem |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | MICROPORT ORTHOPEDICS INC. 5677 AIRLINE RD Arlington, TN 38002 |
| Contact | Matt Paul |
| Correspondent | Matt Paul MICROPORT ORTHOPEDICS INC. 5677 AIRLINE RD Arlington, TN 38002 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-06 |
| Decision Date | 2015-04-10 |
| Summary: | summary |