510(k) K022120

MPF ACETABULAR CUP GENERATION 2 by Plus Orthopedics — Product Code LZO

K022120 is an FDA 510(k) premarket notification submitted by Plus Orthopedics for the device "MPF ACETABULAR CUP GENERATION 2". The FDA issued a decision of Substantially Equivalent on July 24, 2002. 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. Plus Orthopedics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2002
Date Received
July 1, 2002
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