510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K261058Substantially Equivalent

CraniUS Plate

CraniUS, LLC, Baltimore MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K261058 is the FDA 510(k) clearance record for CraniUS Plate, a class II device, cleared for CraniUS, LLC on under FDA product code GWO (Plate, Cranioplasty, Preformed, Alterable). FDA records list one 510(k) clearance for CraniUS, LLC. As of , FDA records show no recalls naming K261058.

Clearance record

Decision date
Received
(120 days to decision)
Product code
GWO Plate, Cranioplasty, Preformed, Alterable
Regulation
21 CFR 882.5320
Device class
Class II
Review panel
Neurology
Applicant
CraniUS, LLC 1700 Union Ave., Suite A1, Baltimore MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GWO

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