Clearance Summary
X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh System, BENGAL Stackable Cage System, BENGAL System, CONCORDE® System, CONCORDE® Inline Lumbar Interbody System, CONCORDE® Curve Lumbar Interbody System, CONCORDE® Bullet Lumbar Interbody System, COUGAR® System, COUGAR® LS Lateral Cage System, DEVEX® System, LEOPARD® System, DePuy PULSE Cervical Cage System, DePuy PULSE Lumbar Cage System, LUMBAR I/F CAGE® System received FDA 510(k) clearance under submission number K173787, sponsored by Medos International SARL. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2018-06-11.
- Submission: K173787
- Applicant / Sponsor: Medos International SARL
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3060
- Decision date: 2018-06-11
Classification & Regulation
This clearance is catalogued under FDA product code MQP and 21 CFR 888.3060, within the Orthopedic review panel as a Class II device.