510(k) K122305

CORIN TRINITY-I ACETABULAR SHELL by Corin USA — Product Code LZO

K122305 is an FDA 510(k) premarket notification submitted by Corin USA for the device "CORIN TRINITY-I ACETABULAR SHELL". The FDA issued a decision of Substantially Equivalent on November 21, 2012. 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. Corin USA has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2012
Date Received
August 1, 2012
Clearance Type
Traditional
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