510(k) K233498

Stryker Orthopaedics Hip Systems Labeling Update by Howmedica Osteonics Corp., Dba Stryker Orthopaedics — Product Code LPH

K233498 is an FDA 510(k) premarket notification submitted by Howmedica Osteonics Corp., Dba Stryker Orthopaedics for the device "Stryker Orthopaedics Hip Systems Labeling Update". The FDA issued a decision of Substantially Equivalent on December 21, 2023. 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. Howmedica Osteonics Corp., Dba Stryker Orthopaedics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2023
Date Received
October 31, 2023
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