Clearance Summary
Intra medullary endo-transilluminating device (iMET device) received FDA 510(k) clearance under submission number K163037, sponsored by WeMED Bio-Tech, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2017-02-17.
- Submission: K163037
- Applicant / Sponsor: WeMED Bio-Tech, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.1100
- Decision date: 2017-02-17
Classification & Regulation
This clearance is catalogued under FDA product code HRX and 21 CFR 888.1100, within the Orthopedic review panel as a Class II device.