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HBW

Fastener, Plate, Cranioplasty

Product code
HBW
Device name
Fastener, Plate, Cranioplasty
Device class
Class 2
21 CFR
21 CFR 882.5360
Medical specialty
Neurology
Marketing pathway
510(K)
Flag
Implant
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
7 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-07-11.

NumberDecision dateApplicantDevice nameSummary
K2514722025-07-11Inion OYInion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System;…PDF

1 summaries are archived here for direct download.

Official FDA classification page: HBW
Classification and pathway per current FDA publications. Data from openFDA (CC0).