510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K222515Substantially Equivalent

FaSet Fixation System

Dio Medical Co., Ltd., East Norriton PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K222515 is the FDA 510(k) clearance record for FaSet Fixation System, cleared for Dio Medical Corporation on under FDA product code MRW (System, Facet Screw Spinal Device). FDA records list 13 510(k) clearances for Dio Medical Corporation, from to . As of , FDA records show no recalls naming K222515.

Clearance record

Decision date
Received
(47 days to decision)
Product code
MRW System, Facet Screw Spinal Device
Device class
Unclassified
Review panel
Unknown
Applicant
Dio Medical Corporation 2100 Campus Ln., East Norriton PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MRW

Trailing 12 months
7 clearances under product code MRW 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 MRW, trailing twelve months
MonthClearances
November 20251
December 20251
January 20261
February 20260
March 20261
April 20260
May 20261
June 20261
July 20260
August 20260
September 20261
October 20260