510(k) K231925

MINIMA S System by Lima Corporate S.P.A. — Product Code LZO

K231925 is an FDA 510(k) premarket notification submitted by Lima Corporate S.P.A. for the device "MINIMA S System". The FDA issued a decision of Substantially Equivalent on July 11, 2023. 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 at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2023
Date Received
June 30, 2023
Clearance Type
Special
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