Home / 510(k) Clearances / K180249

510(k) K180249

OmniPore DUROMAX Surgical Implants by Matrix Surgical Holdings, LLC/Matrix Surgical USA — Product Code JEY

K180249 is an FDA 510(k) premarket notification submitted by Matrix Surgical Holdings, LLC/Matrix Surgical USA for the device "OmniPore DUROMAX Surgical Implants". The FDA issued a decision of Substantially Equivalent on October 11, 2018. The device falls under product code JEY (Plate, Bone), a Class II device regulated under 21 CFR 872.4760. Matrix Surgical Holdings, LLC/Matrix Surgical USA has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2018
Date Received
January 29, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Bone
Device Class
Class II
Regulation Number
872.4760
Review Panel
DE
Submission Type

Other clearances by Matrix Surgical Holdings, LLC/Matrix Surgical USA

  • K133046 — OMNIPORE CUSTOMIZED SURGICAL IMPLANTS (May 14, 2014)

Other clearances for product code JEY

  • K260137 — KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions (August 17, 2026)
  • K253206 — METICULY Patient-specific CMF solution (July 25, 2026)
  • K252246 — Leforte MMF System (April 2, 2026)
  • K253373 — Southern Craniomaxillofacial (CMF) System (December 19, 2025)
  • K251441 — Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsor (November 7, 2025)
  • K241314 — KLS Martin Oral-Max Implants MR Conditional (bundled) (August 16, 2024)
  • K240651 — MRI Universal (July 12, 2024)
  • K233874 — tmCMF Solution (July 11, 2024)
  • K232889 — METICULY Patient-specific titanium maxillofacial mesh implant (April 30, 2024)
  • K232350 — Stryker Facial iD System (January 13, 2024)

FDA data resources