510(k) K200656

Delta Multihole TT Pro Acetabular System by Lima Corporate S.P.A. — Product Code LPH

K200656 is an FDA 510(k) premarket notification submitted by Lima Corporate S.P.A. for the device "Delta Multihole TT Pro Acetabular System". The FDA issued a decision of Substantially Equivalent on Jul 8, 2020. The device falls under product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented), a Class II device regulated under 21 CFR 888.3358. Lima Corporate S.P.A. has 63 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 8, 2020
Date Received
Mar 12, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device Class
Class II
Regulation Number
888.3358
Review Panel
OR
Submission Type
510(k)