510(k) K183472
K183472 is an FDA 510(k) premarket notification submitted by Synthes (USA) Products, LLC for the device "DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio MR Conditional". The FDA issued a decision of Substantially Equivalent on March 13, 2019. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. Synthes (USA) Products, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 13, 2019
- Date Received
- December 14, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- SU
- Submission Type