The following data is part of a premarket notification filed by Microport Orthopedics Inc. with the FDA for Dynasty Shell, Dynasty A-class Crosslinked Poly Liner, Biolox Delta Femoral Head.
| Device ID | K140043 |
| 510k Number | K140043 |
| Device Name: | DYNASTY SHELL, DYNASTY A-CLASS CROSSLINKED POLY LINER, BIOLOX DELTA FEMORAL HEAD |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | MICROPORT ORTHOPEDICS INC. 5677 AIRLINE RD Arlington, TN 38002 |
| Contact | Max Mortensen |
| Correspondent | Max Mortensen 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 | 2014-01-08 |
| Decision Date | 2014-04-03 |
| Summary: | summary |