510(k) K203175
K203175 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "POLARSTEM Cemented Femoral Stem". The FDA issued a decision of Substantially Equivalent on Jul 22, 2021. The device falls under product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented), a Class II device regulated under 21 CFR 888.3353. Smith & Nephew, Inc. has 554 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 22, 2021
- Date Received
- Oct 26, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- Device Class
- Class II
- Regulation Number
- 888.3353
- Review Panel
- OR
- Submission Type
- 510(k)