Clearance Summary
ECTRA LIGAMENT RELEASE SYSTEM received FDA 510(k) clearance under submission number K953387, sponsored by Smith & Nephew Dyonics, 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 1995-08-09.
- Submission: K953387
- Applicant / Sponsor: Smith & Nephew Dyonics, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.1100
- Decision date: 1995-08-09
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.