510(k) K172596
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 2, 2017
- Date Received
- August 29, 2017
- Clearance Type
- Special
- 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