510(k) K203465
OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design by
OSSIO , Ltd.
— Product Code HTY
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 6, 2021
- Date Received
- November 24, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pin, Fixation, Smooth
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type