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)

DUNN ANTERIOR DISTRACTION SYSTEM

K-Number: K862755 · 1987-01-22

ApplicantOsteotek, Inc.
Decision Date1987-01-22
Product Code
DecisionSubstantially Equivalent for Some Indications

Device Summary

DUNN ANTERIOR DISTRACTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Osteotek, Inc.. It received FDA 510(k) clearance on 1987-01-22 under 510(k) number K862755. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the DUNN ANTERIOR DISTRACTION SYSTEM?

DUNN ANTERIOR DISTRACTION SYSTEM is a medical device that received FDA 510(k) clearance on 1987-01-22. The listed applicant is Osteotek, Inc.. The 510(k) number is K862755.

When did DUNN ANTERIOR DISTRACTION SYSTEM receive FDA 510(k) clearance?

DUNN ANTERIOR DISTRACTION SYSTEM received FDA 510(k) clearance on 1987-01-22, under 510(k) number K862755.

Who is the listed applicant for DUNN ANTERIOR DISTRACTION SYSTEM?

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

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

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.

↑