The following data is part of a premarket notification filed by Microport Orthopedics Inc. with the FDA for Advance Porous Coated Spiked Tibial Base.
| Device ID | K143366 |
| 510k Number | K143366 |
| Device Name: | ADVANCE Porous Coated Spiked Tibial Base |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | MicroPort Orthopedics Inc. 5677 Airline Road Arlington, TN 38002 |
| Contact | Caroline Fryar |
| Correspondent | Caroline Fryar MicroPort Orthopedics Inc. 5677 Airline Road Arlington, TN 38002 |
| Product Code | MBH |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-24 |
| Decision Date | 2015-01-21 |
| Summary: | summary |