510(k) K170313
K170313 is an FDA 510(k) premarket notification submitted by Jeil Medical Corporation for the device "ARIX Ankle Distal Tibia System". The FDA issued a decision of Substantially Equivalent on Jul 27, 2017. 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
- Jul 27, 2017
- Date Received
- Feb 1, 2017
- Clearance Type
- Traditional
- 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)