Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE

K-Number: K103136 · 2011-03-18

ApplicantMaterialise NV
Decision Date2011-03-18
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE is the device name listed in this FDA 510(k) record. The listed applicant is Materialise NV. It received FDA 510(k) clearance on 2011-03-18 under 510(k) number K103136. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE?

SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE is a medical device that received FDA 510(k) clearance on 2011-03-18. The listed applicant is Materialise NV. The 510(k) number is K103136.

When did SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE receive FDA 510(k) clearance?

SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE received FDA 510(k) clearance on 2011-03-18, under 510(k) number K103136.

Who is the listed applicant for SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE?

The FDA 510(k) record lists Materialise NV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE?

The FDA product code for SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE is JEY.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Materialise NV as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260802Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerK251964Mimics Thoracic PlannerK253308Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic ModelsK253793Materialise TKA Guide SystemK251554Materialise TKA Guide SystemK243637Materialise Personalized Guides and Models for Craniomaxillofacial Surgery

View all 55 devices →

Related Devices (Code: JEY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient SolutionsKLS-Martin L.P.K253206METICULY Patient-specific CMF solutionMeticuly Co., Ltd.K252246Leforte MMF SystemJeil Medical CorporationK253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty) , Ltd.K251441Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation SystemInion OYK241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑