510(k) K193451
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 24, 2020
- Date Received
- December 13, 2019
- 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