OMNIPORE CUSTOMIZED SURGICAL IMPLANTS— 510(k) K133046

Name: FDA 510(k) clearance K133046
Creator: U.S. Food and Drug Administration
Published: 2014-05-14

Substantially Equivalent

Matrix Surgical Holdings, LLC/Matrix Surgical USA

FDA 510(k) clearance K133046 for OMNIPORE CUSTOMIZED SURGICAL IMPLANTS, Substantially Equivalent on 2014-05-14. Applicant: Matrix Surgical Holdings, LLC/Matrix Surgical USA. Device class: 2.

Clearance details

Applicant: Matrix Surgical Holdings, LLC/Matrix Surgical USA
Product code: Code KKY
Device class: Class 2
Regulation: 21 CFR 878.3500
Advisory panel: General, Plastic Surgery
Date received: 2013-09-27
Decision date: 2014-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alpharetta, GA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K133046

K-number listed on FDA's recall record

Z-1382-2017 — OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - RightClass II·Terminated·Matrix Surgical Holdings, LLC·20170125

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133046.

Data sourced from openFDA. This site is unofficial and independent of the FDA.