510(k) K221149

U-Motion II Acetabular System-Extension line by United Orthopedic Corporation — Product Code LZO

K221149 is an FDA 510(k) premarket notification submitted by United Orthopedic Corporation for the device "U-Motion II Acetabular System-Extension line". The FDA issued a decision of Substantially Equivalent on January 5, 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. United Orthopedic Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 2023
Date Received
April 20, 2022
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