510(k) K173606
K173606 is an FDA 510(k) premarket notification submitted by SeaSpine Orthopedics Corporation for the device "SeaSpine Vu aPOD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu aPOD Prime Intervertebral Body Fusion Device". The FDA issued a decision of Substantially Equivalent on Apr 13, 2018. The device falls under product code OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar), a Class II device regulated under 21 CFR 888.3080. SeaSpine Orthopedics Corporation has 66 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 13, 2018
- Date Received
- Nov 21, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Intervertebral Fusion Device With Integrated Fixation, Lumbar
- Device Class
- Class II
- Regulation Number
- 888.3080
- Review Panel
- OR
- Submission Type
- 510(k)
Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.