FDA 510(k) Applications for Medical Device Product Code: HBW (Fastener, Plate, Cranioplasty)

FDA 510(k) Applications for Medical Device Product Code "HBW"
(Fastener, Plate, Cranioplasty)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K001353	BIOMEDICAL ENT., INC.	MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM	03/13/2001
K141385	DEPUY SYNTHES COMPANIES OF JOHNSON & JOHNSON	DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS)	03/27/2015
K251472	Inion Oy	Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System	07/11/2025
K101835	POREX SURGICAL, INC.	MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079	12/03/2010
K171152	Stryker	Stryker Universal Neuro III System AXS Screw	05/19/2017
K151387	STRYKER	Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade	06/24/2015
K231208	Stryker Leibinger GmbH & Co. KG	Stryker Resorbable Fixation System	08/14/2023