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)

#CTO 100 (CERVICAL TRACTION ORTHOSIS 100)

K-Number: K861470 · 1986-05-02

ApplicantApplied Medical Systems
Decision Date1986-05-02
Product CodeHAX
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

#CTO 100 (CERVICAL TRACTION ORTHOSIS 100) is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Systems. It received FDA 510(k) clearance on 1986-05-02 under 510(k) number K861470. The device is classified under product code HAX. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the #CTO 100 (CERVICAL TRACTION ORTHOSIS 100)?

#CTO 100 (CERVICAL TRACTION ORTHOSIS 100) is a medical device that received FDA 510(k) clearance on 1986-05-02. The listed applicant is Applied Medical Systems. The 510(k) number is K861470.

When did #CTO 100 (CERVICAL TRACTION ORTHOSIS 100) receive FDA 510(k) clearance?

#CTO 100 (CERVICAL TRACTION ORTHOSIS 100) received FDA 510(k) clearance on 1986-05-02, under 510(k) number K861470.

Who is the listed applicant for #CTO 100 (CERVICAL TRACTION ORTHOSIS 100)?

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

What is the FDA product code for #CTO 100 (CERVICAL TRACTION ORTHOSIS 100)?

The FDA product code for #CTO 100 (CERVICAL TRACTION ORTHOSIS 100) is HAX.

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

Related Devices (Code: HAX)

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.

K090733PMT HALO SYSTEMPmt Corp.K071173RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100DOssur Americans (Formerly the Jerome Group)K051918RESOLVE OPEN BACK HALO RINGSJerome MedicalK023959JEROME GLASS RINGThe Jerome Group, Inc.K003662SPINE WORKS COLLARSpine WorksK980689FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEMFriddle'S Orthopedic Appliances, 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.

↑