510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K250334Substantially Equivalent

Fusion Craniofacial Implant; Fusion Skull Implant

Kelyniam Global, Inc., Canton CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250334 is the FDA 510(k) clearance record for Fusion Craniofacial Implant; Fusion Skull Implant, a class II device, cleared for Kelyniam Global, Inc. on under FDA product code GWO (Plate, Cranioplasty, Preformed, Alterable). FDA records list 4 510(k) clearances for Kelyniam Global, Inc., from to . As of , FDA records show no recalls naming K250334.

Clearance record

Decision date
Received
(170 days to decision)
Product code
GWO Plate, Cranioplasty, Preformed, Alterable
Regulation
21 CFR 882.5320
Device class
Class II
Review panel
Neurology
Applicant
Kelyniam Global, Inc. 97 River Rd., Suite A, Canton CT
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