510(k) K131647

TRINITY ACETABULAR SYSTEM by Corin USA — Product Code LZO

K131647 is an FDA 510(k) premarket notification submitted by Corin USA for the device "TRINITY ACETABULAR SYSTEM". The FDA issued a decision of Substantially Equivalent on September 27, 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. Corin USA has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2013
Date Received
June 5, 2013
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