510(k) K130343

CORIN TRINITY ACETABULAR SYSTEM WITH EXTRA-LONG HEADS by Corin USA — Product Code LZO

K130343 is an FDA 510(k) premarket notification submitted by Corin USA for the device "CORIN TRINITY ACETABULAR SYSTEM WITH EXTRA-LONG HEADS". The FDA issued a decision of Substantially Equivalent on May 28, 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
May 28, 2013
Date Received
February 11, 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