510(k) K213126
K213126 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws". The FDA issued a decision of Substantially Equivalent on September 29, 2022. The device falls under product code JDO (Device, Fixation, Proximal Femoral, Implant), a Class II device regulated under 21 CFR 888.3030. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 29, 2022
- Date Received
- September 27, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Fixation, Proximal Femoral, Implant
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type