510(k) K201157
K201157 is an FDA 510(k) premarket notification submitted by Microport Orthopedics, Inc. for the device "Prime BIOFOAM® Multi-Hole Shells". The FDA issued a decision of Substantially Equivalent on August 24, 2021. The device falls under product code MBL (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous), a Class II device regulated under 21 CFR 888.3358. Microport Orthopedics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 24, 2021
- Date Received
- April 30, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
- Device Class
- Class II
- Regulation Number
- 888.3358
- Review Panel
- OR
- Submission Type