510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NVRClass III

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

Unknown
FDA source (opens on fda.gov)

NVR is the FDA product code for Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar, a class III device type. FDA's definition for this code reads: "Intended to be inserted between the vertebral bodies into the disc space from l3 to s1 to provide stabilization and to help promote intervertebral body fusion. To be used with bone graft, for holding bone parts in alignment while they heal. Not intended for use in motion-sparing, non-fusion procedures, helps promote...". As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and 17 recalls.

Classification record

Product code
NVR
Device name
Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar
FDA definition
Intended to be inserted between the vertebral bodies into the disc space from l3 to s1 to provide stabilization and to help promote intervertebral body fusion. To be used with bone graft, for holding bone parts in alignment while they heal. Not intended for use in motion-sparing, non-fusion procedures, helps promote intervertebral body fusion, please reference: https://www.federalregister.gov/documents/2023/03/30/2023-06566/medical-devices-orthopedic-devices-classification-of-spinal-spheres-for-use-in-intervertebral-fusion.
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
6
Ingested recalls
17

Clearances, product code NVR

By decision year
6 clearances under product code NVR with a decision year between 2005 and 2008, 2007 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code NVR by decision year
YearClearances
20051
20073
20082

Applicants with the most clearances

Product code NVR
Applicants holding the most 510(k) clearances under product code NVR
ApplicantClearances
Interbody Innovations, LLP2
Medtronic Sofamor Danek2
Highridge Medical, LLC1
Life Spine1

Companies listing this code with FDA

Companies whose registered establishments list this code