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FDA 510(k)

CERVICAL BRACE

K-Number: K822780 · 1982-10-06

ApplicantJerome Medical
Decision Date1982-10-06
Product CodeJEC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CERVICAL BRACE is the device name listed in this FDA 510(k) record. The listed applicant is Jerome Medical. It received FDA 510(k) clearance on 1982-10-06 under 510(k) number K822780. The device is classified under product code JEC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CERVICAL BRACE?

CERVICAL BRACE is a medical device that received FDA 510(k) clearance on 1982-10-06. The listed applicant is Jerome Medical. The 510(k) number is K822780.

When did CERVICAL BRACE receive FDA 510(k) clearance?

CERVICAL BRACE received FDA 510(k) clearance on 1982-10-06, under 510(k) number K822780.

Who is the listed applicant for CERVICAL BRACE?

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 CERVICAL BRACE?

The FDA product code for CERVICAL BRACE is JEC.

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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.

K051918RESOLVE OPEN BACK HALO RINGSK930021J TONGSK930153SYSTEM III HALO RINGK882877JMS CERVICAL TRACTION DEVICE/HALO DEVICEK870053TORQUEDRIVER WRENCHK864969JMS HALO APPLICATION TRAY

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Related Devices (Code: JEC)

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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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