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FDA 510(k)

FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM

K-Number: K980689 · 1999-02-18

ApplicantFriddle'S Orthopedic Appliances, Inc.
Decision Date1999-02-18
Product CodeHAX
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Friddle'S Orthopedic Appliances, Inc.. It received FDA 510(k) clearance on 1999-02-18 under 510(k) number K980689. 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 FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM?

FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM is a medical device that received FDA 510(k) clearance on 1999-02-18. The listed applicant is Friddle'S Orthopedic Appliances, Inc.. The 510(k) number is K980689.

When did FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM receive FDA 510(k) clearance?

FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM received FDA 510(k) clearance on 1999-02-18, under 510(k) number K980689.

Who is the listed applicant for FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM?

The FDA 510(k) record lists Friddle'S Orthopedic Appliances, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM?

The FDA product code for FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM is HAX.

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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 WorksK930021J 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.

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