Clearance Summary
TRANSFX INTERMEDIATE EXTERNAL FIXATION SYSTEM,TRANSFX SMALL EXTERNAL FIXATION SYSTEM, TRANSFX MINI EXTERNAL FIXATION received FDA 510(k) clearance under submission number K990848, sponsored by Immedica, 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 1999-05-17.
- Submission: K990848
- Applicant / Sponsor: Immedica, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 1999-05-17
Classification & Regulation
This clearance is catalogued under FDA product code LXT and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.