510(k) K170473

C2 femoral stem by Lima Corporate S.P.A. — Product Code LZO

K170473 is an FDA 510(k) premarket notification submitted by Lima Corporate S.P.A. for the device "C2 femoral stem". The FDA issued a decision of Substantially Equivalent on Nov 8, 2017. 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. Lima Corporate S.P.A. has 63 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 8, 2017
Date Received
Feb 16, 2017
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
510(k)