The following data is part of a premarket notification filed by Microport Orthopedics, Inc. with the FDA for Biofoam® Additive Manufacturing (biofoam® Am), Advance® Biofoam® Tibial Base, Evolution® Biofoam® Tibial Base, Dynasty® Biofoam® Acetabular Shell.
Device ID | K170288 |
510k Number | K170288 |
Device Name: | BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION® BIOFOAM® Tibial Base, DYNASTY® BIOFOAM® Acetabular Shell |
Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
Applicant | MicroPort Orthopedics, Inc. 5677 Airline Road Arlington, TN 38002 |
Contact | Grace Johnson-bann |
Correspondent | Grace Johnson-bann 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 | 2017-01-30 |
Decision Date | 2017-06-15 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() BIOFOAM 97757507 not registered Live/Pending |
US BioSolutions LLC 2023-01-17 |
![]() BIOFOAM 97107943 not registered Live/Pending |
Aphex BioCleanse Systems, Inc. 2021-11-04 |
![]() BIOFOAM 90488066 not registered Live/Pending |
Zinus Inc. 2021-01-26 |
![]() BIOFOAM 90181607 not registered Live/Pending |
US BIOSOLUTIONS LLC 2020-09-15 |
![]() BIOFOAM 86327225 4960825 Live/Registered |
GlassCraft Door I Limited Partnership 2014-07-02 |
![]() BIOFOAM 85595305 not registered Dead/Abandoned |
Mechanix Wear, Inc. 2012-04-11 |
![]() BIOFOAM 85180957 not registered Dead/Abandoned |
Bioplanet Corp 2010-11-19 |
![]() BIOFOAM 85119713 4074943 Live/Registered |
Let's Gel, Inc. 2010-08-31 |
![]() BIOFOAM 78939962 3350373 Dead/Cancelled |
Menzel, Chuck 2006-07-28 |
![]() BIOFOAM 78424913 3149576 Live/Registered |
CRYOLIFE, INC. 2004-05-25 |
![]() BIOFOAM 77852341 3877964 Live/Registered |
ZINUS INC. 2009-10-20 |
![]() BIOFOAM 77647792 not registered Dead/Abandoned |
Menzel, Charles H. 2009-01-12 |