510(k) K130128

TRINITY ACETABULAR SYSTEM by Corin Medical — Product Code LZO

K130128 is an FDA 510(k) premarket notification submitted by Corin Medical for the device "TRINITY ACETABULAR SYSTEM". The FDA issued a decision of Substantially Equivalent on March 8, 2013. 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.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 2013
Date Received
January 17, 2013
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