510(k) K203228
K203228 is an FDA 510(k) premarket notification submitted by Wright Medical for the device "DART-FIRE EDGE Cannulated Screw System". The FDA issued a decision of Substantially Equivalent on May 11, 2021. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Wright Medical has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 11, 2021
- Date Received
- November 2, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Screw, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type