510(k) K173787
K173787 is an FDA 510(k) premarket notification submitted by Medos International SARL for the device "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". The FDA issued a decision of Substantially Equivalent on Jun 11, 2018. The device falls under product code MQP (Spinal Vertebral Body Replacement Device), a Class II device regulated under 21 CFR 888.3060. Medos International SARL has 95 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 11, 2018
- Date Received
- Dec 14, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Spinal Vertebral Body Replacement Device
- Device Class
- Class II
- Regulation Number
- 888.3060
- Review Panel
- OR
- Submission Type
- 510(k)