Db-Cmf

FDA 510(k) K182742 · Dimensional Bioceramics, LLC

Substantially Equivalent

510(k) numberK182742

Submission

Device name
Db-Cmf
Applicant
Dimensional Bioceramics, LLC
Santa Cruz, CA, US
Received
September 28, 2018
Decision date
June 20, 2019
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)DeviceApplicantDecision
K251959TnR Cranial ImplantGXP · Traditional T&R BIOFAB CO., Ltd.07/30/2026SE
K261265Permatage XT Settable Bone PuttyGXP · Special Orthocon, Inc.06/15/2026SE
K253732Permatage Flowable, Settable Bone PasteGXP · Traditional Orthocon, Inc.03/13/2026SE
K253854MONTAGE XT Cranial CementGXP · Special Orthocon, Inc.01/02/2026SE
K241027Permatage Settable Bone PuttyGXP · Traditional Orthocon, Inc.09/26/2024SE
K232771Montage Flowable Settable, Resorbable Bone PasteGXP · Traditional Orthocon, Inc.02/16/2024SE
K231475MONTAGE-QS Settable, Resorbable Bone PuttyGXP · Traditional Orthocon, Inc.10/12/2023SE
K221933MONTAGE Settable, Resorbable Bone PuttyGXP · Traditional Orthocon, Inc.01/13/2023SE
K162864OsteoVation ImpactGXP · Traditional Skeletal Kinetics, LLC01/13/2017SE
K143661DirectInjectGXP · Traditional Stryker09/02/2015SE

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K200752DB-OrthopedicsMQV · Traditional 04/22/2020SE
K171161Dimensional Bioceramics Calcium Sulfate Device (DB-CSD)MQV · Traditional 09/25/2017SE

Questions and answers

When was Db-Cmf cleared by the FDA?

Db-Cmf (K182742) received a 510(k) decision of Substantially Equivalent on June 20, 2019, 265 days after the submission was received.

What is the product code of K182742?

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