Cap Bone Substitute Material

Q: What is the product code of K032307?

The FDA product code is GXP – Methyl Methacrylate For Cranioplasty, a Class II (moderate risk) device regulated under 21 CFR 882.5300.

FDA 510(k) K032307 · Etex Corp.

Substantially Equivalent

510(k) numberK032307

Submission

Device name: Cap Bone Substitute Material
Applicant: Etex Corp.
Cambridge, MA, US
Received: July 25, 2003
Decision date: October 24, 2003
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: GXP – Methyl Methacrylate For Cranioplasty
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.5300
Specialty: Neurology
Implant: Yes

Other 510(k)s with product code GXP

510(k)	Device	Applicant	Decision
K251959	TnR Cranial ImplantGXP · Traditional	T&R BIOFAB CO., Ltd.	07/30/2026SE
K261265	Permatage XT Settable Bone PuttyGXP · Special	Orthocon, Inc.	06/15/2026SE
K253732	Permatage Flowable, Settable Bone PasteGXP · Traditional	Orthocon, Inc.	03/13/2026SE
K253854	MONTAGE XT Cranial CementGXP · Special	Orthocon, Inc.	01/02/2026SE
K241027	Permatage Settable Bone PuttyGXP · Traditional	Orthocon, Inc.	09/26/2024SE
K232771	Montage Flowable Settable, Resorbable Bone PasteGXP · Traditional	Orthocon, Inc.	02/16/2024SE
K231475	MONTAGE-QS Settable, Resorbable Bone PuttyGXP · Traditional	Orthocon, Inc.	10/12/2023SE
K221933	MONTAGE Settable, Resorbable Bone PuttyGXP · Traditional	Orthocon, Inc.	01/13/2023SE
K182742	Db-CmfGXP · Traditional	Dimensional Bioceramics, LLC	06/20/2019SE
K162864	OsteoVation ImpactGXP · Traditional	Skeletal Kinetics, LLC	01/13/2017SE

More from Skeletal Kinetics, LLC

510(k)	Device	Decision
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K182107	CarriGen PFMQV · Special	08/31/2018SE
K132868	CarricellMQV · Traditional	02/20/2015SE
K141245	Etex Mixing and Delivery SystemFMF · Traditional	07/09/2014SE
K100883	CarrigenLYC · Traditional	12/21/2010SE
K102812	Gamma-Bsm; Beta-Bsm; EquivaboneLYC · Special	12/03/2010SE
K101557	Gamma-Bsm, Beta-Bsm, Equivabone, CarigenMQV · Special	07/01/2010SE
K093447	CarrigenMQV · Special	02/18/2010SE
K091729	Alpha-Bsm, Beta-Bsm, Gamma-Bsm, EquivaboneLYC · Traditional	12/23/2009SE
K091607	Alpha-Bsm, Beta-Bsm, Gamma-Bsm, EquivaboneMQV · Traditional	11/02/2009SE

Questions and answers

When was Cap Bone Substitute Material cleared by the FDA?

Cap Bone Substitute Material (K032307) received a 510(k) decision of Substantially Equivalent on October 24, 2003, 91 days after the submission was received.

What is the product code of K032307?

The FDA product code is GXP – Methyl Methacrylate For Cranioplasty, a Class II (moderate risk) device regulated under 21 CFR 882.5300.