510(k) K242249

Conformity Stem Extension Line by United Orthopedic Corporation — Product Code LZO

K242249 is an FDA 510(k) premarket notification submitted by United Orthopedic Corporation for the device "Conformity Stem Extension Line". The FDA issued a decision of Substantially Equivalent on August 30, 2024. 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
August 30, 2024
Date Received
July 31, 2024
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