510(k) K180580
Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices by
Surgical Instrument Service and Savings, Inc.
— Product Code KTT
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 27, 2018
- Date Received
- March 5, 2018
- 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