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)

MODUS TITANIUM OSTEOSYNTHESIS SYSTEM

K-Number: K050934 · 2005-05-05

ApplicantMedartis, Inc.
Decision Date2005-05-05
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MODUS TITANIUM OSTEOSYNTHESIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medartis, Inc.. It received FDA 510(k) clearance on 2005-05-05 under 510(k) number K050934. 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 MODUS TITANIUM OSTEOSYNTHESIS SYSTEM?

MODUS TITANIUM OSTEOSYNTHESIS SYSTEM is a medical device that received FDA 510(k) clearance on 2005-05-05. The listed applicant is Medartis, Inc.. The 510(k) number is K050934.

When did MODUS TITANIUM OSTEOSYNTHESIS SYSTEM receive FDA 510(k) clearance?

MODUS TITANIUM OSTEOSYNTHESIS SYSTEM received FDA 510(k) clearance on 2005-05-05, under 510(k) number K050934.

Who is the listed applicant for MODUS TITANIUM OSTEOSYNTHESIS SYSTEM?

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

What is the FDA product code for MODUS TITANIUM OSTEOSYNTHESIS SYSTEM?

The FDA product code for MODUS TITANIUM OSTEOSYNTHESIS SYSTEM 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 Medartis, Inc. 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.

K232324StealthFix Intraosseous Fixation SystemK052061MODUS IMF SCREWS 2.0K051567APTUS TITANIUM OSTEOSYNTHESIS SYSTEMK051946MODUS MODULAR DISTRACTION OSTEOGENESIS SYSTEM

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.

↑