OmniPore DUROMAX Surgical Implants

Q: What is the product code of K180249?

The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.

FDA 510(k) K180249 · Matrix Surgical Holdings, LLC/Matrix Surgical USA

Substantially Equivalent

510(k) numberK180249

Submission

Device name: OmniPore DUROMAX Surgical Implants
Applicant: Matrix Surgical Holdings, LLC/Matrix Surgical USA
Atlanta, GA, US
Received: January 29, 2018
Decision date: October 11, 2018
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: JEY – Plate, Bone
Device class: Class II (moderate risk)
Regulation: 21 CFR 872.4760
Specialty: Dental
Implant: Yes

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K253373	Southern Craniomaxillofacial (CMF) SystemJEY · Traditional	Southern Medical (Pty) , Ltd.	12/19/2025SE
K251441	Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable…JEY · Traditional	Inion OY	11/07/2025SE
K241314	KLS Martin Oral-Max Implants MR Conditional (bundled)JEY · Traditional	KLS-Martin L.P.	08/16/2024SE
K240651	MRI UniversalJEY · Traditional	Stryker Leibinger GmbH & Co KG	07/12/2024SE
K233874	tmCMF SolutionJEY · Traditional	Techmah Cmf	07/11/2024SE
K232889	METICULY Patient-specific titanium maxillofacial mesh implantJEY · Traditional	Meticuly Co., Ltd.	04/30/2024SE
K232350	Stryker Facial iD SystemJEY · Traditional	Stryker Craniomaxillofacial	01/13/2024SE

More from Stryker Craniomaxillofacial

510(k)	Device	Decision
K133046	Omnipore Customized Surgical ImplantsKKY · Traditional	05/14/2014SE

Questions and answers

When was OmniPore DUROMAX Surgical Implants cleared by the FDA?

OmniPore DUROMAX Surgical Implants (K180249) received a 510(k) decision of Substantially Equivalent on October 11, 2018, 255 days after the submission was received.

What is the product code of K180249?

The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.