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FDA 510(k)

HALO TRACTION CERVICAL IMMOBILIZATION

K-Number: K822885 · 1982-11-22

ApplicantOrthopedic Systems, Inc.
Decision Date1982-11-22
Product CodeHAX
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

HALO TRACTION CERVICAL IMMOBILIZATION is the device name listed in this FDA 510(k) record. The listed applicant is Orthopedic Systems, Inc.. It received FDA 510(k) clearance on 1982-11-22 under 510(k) number K822885. 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 HALO TRACTION CERVICAL IMMOBILIZATION?

HALO TRACTION CERVICAL IMMOBILIZATION is a medical device that received FDA 510(k) clearance on 1982-11-22. The listed applicant is Orthopedic Systems, Inc.. The 510(k) number is K822885.

When did HALO TRACTION CERVICAL IMMOBILIZATION receive FDA 510(k) clearance?

HALO TRACTION CERVICAL IMMOBILIZATION received FDA 510(k) clearance on 1982-11-22, under 510(k) number K822885.

Who is the listed applicant for HALO TRACTION CERVICAL IMMOBILIZATION?

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

What is the FDA product code for HALO TRACTION CERVICAL IMMOBILIZATION?

The FDA product code for HALO TRACTION CERVICAL IMMOBILIZATION is HAX.

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Other records listing Orthopedic Systems, Inc. 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.

K952495ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEMK920256SPINE MOTION ANALYZER WITH EMGK910736JACKSON MULTIPURPOSE OPERATING TABLEK910031PARK CITY SHOULDER POSITIONERK903938C FIT CUPK892503NUFFIELD TOTAL KNEE

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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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