510(k) K081614
K081614 is an FDA 510(k) premarket notification submitted by Interbody Innovations, Llp for the device "ZEUS SMALL CERVICAL CAGE AND LARGE, EXTRA LARGE, CURVED AND STRAIGHT LUMBAR CAGES". The FDA issued a decision of Substantially Equivalent on September 5, 2008. The device falls under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical), a Class II device regulated under 21 CFR 888.3080. Interbody Innovations, Llp has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 5, 2008
- Date Received
- June 9, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Intervertebral Fusion Device With Bone Graft, Cervical
- Device Class
- Class II
- Regulation Number
- 888.3080
- Review Panel
- OR
- Submission Type
Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.