510(k) K201733
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)