HBWClass II

Fastener, Plate, Cranioplasty

21 CFR 882.5360 / Neurology

HBW is the FDA product code for Fastener, Plate, Cranioplasty, a class II device type, regulated under 21 CFR 882.5360. As of 2026-09-10, FDA records hold 7 510(k) clearances under this code, the most recent dated 2025-07-11, and one recall.

Classification record

Product code: HBW
Device name: Fastener, Plate, Cranioplasty
Regulation: 21 CFR 882.5360
Device class: Class II
Review panel: Neurology
Submission type: 510(k)
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 7
Ingested recalls: 1

Clearances, product code HBW

By decision year

7 clearances under product code HBW with a decision year between 2001 and 2025, 2015 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code HBW by decision year
Year	Clearances
2001	1
2010	1
2015	2
2017	1
2023	1
2025	1

Applicants with the most clearances

Product code HBW

Applicants holding the most 510(k) clearances under product code HBW
Applicant	Clearances
Stryker Corp.	2
Biomedical Ent., Inc.	1
Depuy Synthes Companies of Johnson & Johnson	1
Inion Oy	1
Porex Surgical, Inc.	1
Stryker Leibinger GmbH & Co. KG	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 33 companies shown, in name order