The following data is part of a premarket notification filed by Microport Orthopedics, Inc. with the FDA for Evolution Biofoam Tibial Base, Evolution Modular Keels, Advance Modular Keels, Advance Bullet-tipped Keels, Advance Biofoam Tibial Base.
| Device ID | K152298 |
| 510k Number | K152298 |
| Device Name: | EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels, ADVANCE Bullet-Tipped Keels, ADVANCE BIOFOAM 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 | Byron Ledbetter |
| Correspondent | Byron Ledbetter MICROPORT ORTHOPEDICS, INC. 5677 AIRLINE ROAD Arlington, TN 38002 |
| Product Code | MBH |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-13 |
| Decision Date | 2015-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M684ETPSB2PR1 | K152298 | 000 |