510(k) K180832
K180832 is an FDA 510(k) premarket notification submitted by Wrightmedicaltechnologyinc for the device "SALVATION External Fixation System". The FDA issued a decision of Substantially Equivalent on Jun 6, 2018. The device falls under product code KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component), a Class II device regulated under 21 CFR 888.3030. Wrightmedicaltechnologyinc has 301 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 6, 2018
- Date Received
- Mar 30, 2018
- Clearance Type
- Special
- 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
- 510(k)