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)

ORAL OSTEODISTRACTION ROD APPLIANCE (ROD 5)

K-Number: K042278 · 2005-01-28

ApplicantOral Osteodistraction, L.P.
Decision Date2005-01-28
Product CodeMQN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORAL OSTEODISTRACTION ROD APPLIANCE (ROD 5) is the device name listed in this FDA 510(k) record. The listed applicant is Oral Osteodistraction, L.P.. It received FDA 510(k) clearance on 2005-01-28 under 510(k) number K042278. The device is classified under product code MQN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORAL OSTEODISTRACTION ROD APPLIANCE (ROD 5)?

ORAL OSTEODISTRACTION ROD APPLIANCE (ROD 5) is a medical device that received FDA 510(k) clearance on 2005-01-28. The listed applicant is Oral Osteodistraction, L.P.. The 510(k) number is K042278.

When did ORAL OSTEODISTRACTION ROD APPLIANCE (ROD 5) receive FDA 510(k) clearance?

ORAL OSTEODISTRACTION ROD APPLIANCE (ROD 5) received FDA 510(k) clearance on 2005-01-28, under 510(k) number K042278.

Who is the listed applicant for ORAL OSTEODISTRACTION ROD APPLIANCE (ROD 5)?

The FDA 510(k) record lists Oral Osteodistraction, L.P. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORAL OSTEODISTRACTION ROD APPLIANCE (ROD 5)?

The FDA product code for ORAL OSTEODISTRACTION ROD APPLIANCE (ROD 5) is MQN.

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 Oral Osteodistraction, L.P. 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.

K034045ORAL OSTEODISTRACTION DISTRACTION ROD APPLIANCES, ROD 4K014001DISTRACTION OSTEOGENESIS ROD APPLIANCES, MODELS 1, 2, AND 3

Related Devices (Code: MQN)

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.

K220050KLS Martin IPS DistractionKLS Martin L.P.K183113DePuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLCK181504Stryker Pediatric Mandibular Distractor 2StrykerK162594Craniomaxillofacial Distraction System (CMFD)Synthes USA Products, LLCK161470Internal Distraction - SterileKLS Martin L.P.K121502SYNTHES CURVILINEAR DISTRACTION SYSTEMSynthes, Inc.

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.

↑