510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191778Substantially Equivalent

Omnia Medical VBR

Omnia Medical, Morgantown, WV / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191778 is the FDA 510(k) clearance record for Omnia Medical VBR, a class II device, cleared for Omnia Medical, LLC 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 11 510(k) clearances for Omnia Medical, LLC, from to . As of , FDA records show no recalls naming K191778.

Clearance record

Decision date
Received
(57 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
Omnia Medical, LLC 6 Canyon Rd., Suite 300, Morgantown, WV
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