510(k) K103517

TRABECULAR METAL FEMORAL CONE AUGMENTS by Zimmer Trabecular Metal Technology, Inc. — Product Code MBH

K103517 is an FDA 510(k) premarket notification submitted by Zimmer Trabecular Metal Technology, Inc. for the device "TRABECULAR METAL FEMORAL CONE AUGMENTS". The FDA issued a decision of Substantially Equivalent on February 15, 2011. 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, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 2011
Date Received
November 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