Clearance Summary
J-FX BIPOLAR HEAD received FDA 510(k) clearance under submission number K980801, sponsored by Johnson & Johnson Professionals, 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 1998-05-29.
- Submission: K980801
- Applicant / Sponsor: Johnson & Johnson Professionals, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3390
- Decision date: 1998-05-29
Classification & Regulation
This clearance is catalogued under FDA product code KWY and 21 CFR 888.3390, within the Orthopedic review panel as a Class II device.