510(k) K161746
K161746 is an FDA 510(k) premarket notification submitted by Jeil Medical Corporation for the device "ARIX Hand System". The FDA issued a decision of Substantially Equivalent on Sep 21, 2016. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Jeil Medical Corporation has 52 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 21, 2016
- Date Received
- Jun 24, 2016
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Plate, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type
- 510(k)