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FDA 510(k)

CRUCIOMETER

K-Number: K884483 · 1989-01-18

Decision Date1989-01-18
Product CodeJZE
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

CRUCIOMETER 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 1989-01-18 under 510(k) number K884483. The device is classified under product code JZE. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRUCIOMETER?

CRUCIOMETER is a medical device that received FDA 510(k) clearance on 1989-01-18. The listed applicant is Orthopedic Systems, Inc.. The 510(k) number is K884483.

When did CRUCIOMETER receive FDA 510(k) clearance?

CRUCIOMETER received FDA 510(k) clearance on 1989-01-18, under 510(k) number K884483.

Who is the listed applicant for CRUCIOMETER?

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 CRUCIOMETER?

The FDA product code for CRUCIOMETER is JZE.

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.

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.

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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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