510(k) K171911
Medline ReNewal Reprocessed Synthes External Fixation Systems by
Surgical Instrument Service and Savings, Inc.
— Product Code KTT
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 9, 2017
- Date Received
- June 26, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type