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FDA 510(k)

BREMER HALO SYSTEM

K-Number: K864746 · 1986-12-22

ApplicantBremer Orthopedics
Decision Date1986-12-22
Product CodeHAX
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BREMER HALO SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bremer Orthopedics. It received FDA 510(k) clearance on 1986-12-22 under 510(k) number K864746. 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 BREMER HALO SYSTEM?

BREMER HALO SYSTEM is a medical device that received FDA 510(k) clearance on 1986-12-22. The listed applicant is Bremer Orthopedics. The 510(k) number is K864746.

When did BREMER HALO SYSTEM receive FDA 510(k) clearance?

BREMER HALO SYSTEM received FDA 510(k) clearance on 1986-12-22, under 510(k) number K864746.

Who is the listed applicant for BREMER HALO SYSTEM?

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

What is the FDA product code for BREMER HALO SYSTEM?

The FDA product code for BREMER HALO SYSTEM is HAX.

Related Clinical Trials

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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.

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