SeaSpine® Vu aPOD Prime NanoMetalene® Intervertebral Body Fusion Device
FDA 510(k) K162351 · SeaSpine Orthopedics Corporation
510(k) numberK162351
Submission
- Device name
- SeaSpine® Vu aPOD Prime NanoMetalene® Intervertebral Body Fusion Device
- Applicant
- SeaSpine Orthopedics Corporation
Carlsbad, CA, US - Received
- August 23, 2016
- Decision date
- December 1, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
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.
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Questions and answers
When was SeaSpine® Vu aPOD Prime NanoMetalene® Intervertebral Body Fusion Device cleared by the FDA?
SeaSpine® Vu aPOD Prime NanoMetalene® Intervertebral Body Fusion Device (K162351) received a 510(k) decision of Substantially Equivalent on December 1, 2016, 100 days after the submission was received.
What is the product code of K162351?
The FDA product code is OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.