510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K192145Substantially Equivalent

Galileo Vertebral Body Replacement Device

Bright Spine, Boca Raton FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K192145 is the FDA 510(k) clearance record for Galileo Vertebral Body Replacement Device, a class II device, cleared for Bright Spine on under FDA product code PLR (Spinal Vertebral Body Replacement Device - Cervical). FDA's definition for product code PLR reads: "Vertebral body replacement in the cervical spine". FDA records list 3 510(k) clearances for Bright Spine, from to . As of , FDA records show no recalls naming K192145.

Clearance record

Decision date
Received
(257 days to decision)
Product code
PLR Spinal Vertebral Body Replacement Device - Cervical
Regulation
21 CFR 888.3060
Device class
Class II
Review panel
Orthopedic
Applicant
Bright Spine 799 NE 71st St., Boca Raton FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PLR

Trailing 12 months
2 clearances under product code PLR in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PLR, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260