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)

SIS SINUS IMPLANT STABILIZER

K-Number: K062436 · 2007-07-30

ApplicantMondeal Medical Systems GmbH
Decision Date2007-07-30
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SIS SINUS IMPLANT STABILIZER is the device name listed in this FDA 510(k) record. The listed applicant is Mondeal Medical Systems GmbH. It received FDA 510(k) clearance on 2007-07-30 under 510(k) number K062436. 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 SIS SINUS IMPLANT STABILIZER?

SIS SINUS IMPLANT STABILIZER is a medical device that received FDA 510(k) clearance on 2007-07-30. The listed applicant is Mondeal Medical Systems GmbH. The 510(k) number is K062436.

When did SIS SINUS IMPLANT STABILIZER receive FDA 510(k) clearance?

SIS SINUS IMPLANT STABILIZER received FDA 510(k) clearance on 2007-07-30, under 510(k) number K062436.

Who is the listed applicant for SIS SINUS IMPLANT STABILIZER?

The FDA 510(k) record lists Mondeal Medical Systems GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIS SINUS IMPLANT STABILIZER?

The FDA product code for SIS SINUS IMPLANT STABILIZER 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 Mondeal Medical Systems GmbH 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.

K072740MONDEAL EXTREMITY BONE FIXATION SYSTEMK071797MONDEAL HAND CONTOUR SYSTEMK071798MONDEAL DISTAL RADIUS SYSTEMK050257LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS) (STERILE)K042345LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS)

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.

↑