Clearance Summary
SYNTHES RIA SYSTEM (EXPANDED INDICATIONS) received FDA 510(k) clearance under submission number K111437, sponsored by Synthes (USA) Products, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2011-08-10.
- Submission: K111437
- Applicant / Sponsor: Synthes (USA) Products, LLC
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4540
- Decision date: 2011-08-10
Classification & Regulation
This clearance is catalogued under FDA product code HTO and 21 CFR 888.4540, within the Orthopedic review panel as a Class I device.