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FDA 510(k)

ORTHO-J, INC. BEK-JS-004

K-Number: K891917 · 1989-05-26

ApplicantOrtho-J, Inc.
Decision Date1989-05-26
Product CodeJEB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ORTHO-J, INC. BEK-JS-004 is the device name listed in this FDA 510(k) record. The listed applicant is Ortho-J, Inc.. It received FDA 510(k) clearance on 1989-05-26 under 510(k) number K891917. The device is classified under product code JEB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHO-J, INC. BEK-JS-004?

ORTHO-J, INC. BEK-JS-004 is a medical device that received FDA 510(k) clearance on 1989-05-26. The listed applicant is Ortho-J, Inc.. The 510(k) number is K891917.

When did ORTHO-J, INC. BEK-JS-004 receive FDA 510(k) clearance?

ORTHO-J, INC. BEK-JS-004 received FDA 510(k) clearance on 1989-05-26, under 510(k) number K891917.

Who is the listed applicant for ORTHO-J, INC. BEK-JS-004?

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

What is the FDA product code for ORTHO-J, INC. BEK-JS-004?

The FDA product code for ORTHO-J, INC. BEK-JS-004 is JEB.

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.

Related Devices (Code: JEB)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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