FDA Device Intelligence
HomeDevice types › NVR

Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar

FDA product code NVR · Class 3 · Unknown

0
Registered devices
27
Adverse events
17
Recalls
6
510(k) clearances

Recent recalls

DateFirmReason
2007-09-13Medtronic Sofamor Danek USA IncLabeling, including indications for use, lack 510 (K) approval
2007-09-13Medtronic Sofamor Danek USA IncLabeling, including indications for use, lack 510 (K) approval
2007-09-13Medtronic Sofamor Danek USA IncSurgical manual/technique lack information required as a condition of the 510(k) approval.
2007-09-13Medtronic Sofamor Danek USA IncLabeling, including indications for use, lack 510 (K) approval
2007-09-13Medtronic Sofamor Danek USA IncLabeling, including indications for use, lack 510 (K) approval
2007-09-13Medtronic Sofamor Danek USA IncLabeling, including indications for use, lack 510 (K) approval
2007-09-13Medtronic Sofamor Danek USA IncLabeling, including indications for use, lack 510 (K) approval
2007-09-13Medtronic Sofamor Danek USA IncSurgical manual lacks information required as a condition of the 510(k) approval.
2007-09-13Medtronic Sofamor Danek USA IncLabeling, including indications for use, lack 510 (K) approval
2007-09-13Medtronic Sofamor Danek USA IncLabeling, including indications for use, lack 510 (K) approval

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.