510(k) K102896

TRABECULAR METAL TIBIAL CONE AUGMENTS by Zimmer Trabecular Metal Technology — Product Code MBH

K102896 is an FDA 510(k) premarket notification submitted by Zimmer Trabecular Metal Technology for the device "TRABECULAR METAL TIBIAL CONE AUGMENTS". The FDA issued a decision of Substantially Equivalent on December 13, 2010. The device falls under product code MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3565. Zimmer Trabecular Metal Technology has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2010
Date Received
September 30, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3565
Review Panel
OR
Submission Type