510(k) K140915

EXCIA TOTAL HIP SYSTEM by Aesculap Implant Systems, LLC — Product Code LZO

K140915 is an FDA 510(k) premarket notification submitted by Aesculap Implant Systems, LLC for the device "EXCIA TOTAL HIP SYSTEM". The FDA issued a decision of Substantially Equivalent on July 21, 2014. The device falls under product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented), a Class II device regulated under 21 CFR 888.3353. Aesculap Implant Systems, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 2014
Date Received
April 10, 2014
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device Class
Class II
Regulation Number
888.3353
Review Panel
OR
Submission Type