510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K251472Substantially Equivalent

Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System

Inion Oy, Tampere, FI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K251472 is the FDA 510(k) clearance record for Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System, a class II device, cleared for Inion OY on under FDA product code HBW (Fastener, Plate, Cranioplasty). FDA records list 37 510(k) clearances for Inion OY, from to . As of , FDA records show no recalls naming K251472.

Clearance record

Decision date
Received
(59 days to decision)
Product code
HBW Fastener, Plate, Cranioplasty
Regulation
21 CFR 882.5360
Device class
Class II
Review panel
Neurology
Applicant
Inion OY Lääkärinkatu 2, Tampere, FI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HBW

Trailing 12 months

FDA records hold no clearances under product code HBW in the trailing twelve months.

FDA records show no clearances under product code HBW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HBW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260