510(k) K201733

Provident II Hip Stems by Globus Medical, Inc. — Product Code LPH

K201733 is an FDA 510(k) premarket notification submitted by Globus Medical, Inc. for the device "Provident II Hip Stems". The FDA issued a decision of Substantially Equivalent on Jul 14, 2021. 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. Globus Medical, Inc. has 173 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 14, 2021
Date Received
Jun 25, 2020
Clearance Type
Special
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
510(k)