510(k) K201348
K201348 is an FDA 510(k) premarket notification submitted by Depuy International, Ltd. for the device "DePuy 3D Additive TriFlange Acetabular Cup". The FDA issued a decision of Substantially Equivalent on Jun 16, 2022. 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.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 16, 2022
- Date Received
- May 21, 2020
- 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
- 510(k)