510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K063139Unknown

Spinal Stabilizing Sphere System

Highridge Medical, LLC, Warsaw IN / Traditional, Unknown
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063139 is the FDA 510(k) clearance record for SPINAL STABILIZING SPHERE SYSTEM, a class III device, cleared for Biomet Spine on under FDA product code NVR (Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar). FDA's definition for product code NVR 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...". FDA records list 40 510(k) clearances for Highridge Medical, LLC, from to . As of , FDA records show no recalls naming K063139.

Clearance record

Decision date
Received
(170 days to decision)
Product code
NVR Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar
Device class
Class III
Review panel
Unknown
Applicant
Biomet Spine P.O. Box 587, Warsaw IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NVR

Trailing 12 months

FDA records hold no clearances under product code NVR in the trailing twelve months.

FDA records show no clearances under product code NVR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NVR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260