510(k) K153772

Corin TriFit TS Hip by Corin U.S.A. Limited — Product Code MEH

K153772 is an FDA 510(k) premarket notification submitted by Corin U.S.A. Limited for the device "Corin TriFit TS Hip". The FDA issued a decision of Substantially Equivalent on Mar 31, 2016. The device falls under product code MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate), a Class II device regulated under 21 CFR 888.3353. Corin U.S.A. Limited has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 31, 2016
Date Received
Dec 31, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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