510(k) K213123
K213123 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "EVOS Wrist Spanning Plate". The FDA issued a decision of Substantially Equivalent on Oct 18, 2022. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Smith & Nephew, Inc. has 554 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 18, 2022
- Date Received
- Sep 27, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type
- 510(k)