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)

RESOLVE OPEN BACK HALO RINGS

K-Number: K051918 · 2005-08-17

ApplicantJerome Medical
Decision Date2005-08-17
Product CodeHAX
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

RESOLVE OPEN BACK HALO RINGS is the device name listed in this FDA 510(k) record. The listed applicant is Jerome Medical. It received FDA 510(k) clearance on 2005-08-17 under 510(k) number K051918. 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 RESOLVE OPEN BACK HALO RINGS?

RESOLVE OPEN BACK HALO RINGS is a medical device that received FDA 510(k) clearance on 2005-08-17. The listed applicant is Jerome Medical. The 510(k) number is K051918.

When did RESOLVE OPEN BACK HALO RINGS receive FDA 510(k) clearance?

RESOLVE OPEN BACK HALO RINGS received FDA 510(k) clearance on 2005-08-17, under 510(k) number K051918.

Who is the listed applicant for RESOLVE OPEN BACK HALO RINGS?

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

What is the FDA product code for RESOLVE OPEN BACK HALO RINGS?

The FDA product code for RESOLVE OPEN BACK HALO RINGS 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

Other records listing Jerome Medical 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.

K930021J TONGSK930153SYSTEM III HALO RINGK882877JMS CERVICAL TRACTION DEVICE/HALO DEVICEK870053TORQUEDRIVER WRENCHK864969JMS HALO APPLICATION TRAYK844490TRACTION ACCESSORIES

View all 9 devices →

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)K023959JEROME GLASS RINGThe Jerome Group, Inc.K003662SPINE WORKS COLLARSpine WorksK980689FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEMFriddle'S Orthopedic Appliances, Inc.K930021J TONGSJerome Medical

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.

↑