510(k) K171966
K171966 is an FDA 510(k) premarket notification submitted by Medacta International S.A. for the device "Mpact® 3D Metal Implants and Augments 3D Metal". The FDA issued a decision of Substantially Equivalent on Mar 27, 2018. 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. Medacta International S.A. has 207 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 27, 2018
- Date Received
- Jun 30, 2017
- 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)