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FDA 510(k)

TRAUMACAD 1.2

K-Number: K042816 · 2004-11-10

ApplicantOrthocrat, Ltd.
Decision Date2004-11-10
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TRAUMACAD 1.2 is the device name listed in this FDA 510(k) record. The listed applicant is Orthocrat, Ltd.. It received FDA 510(k) clearance on 2004-11-10 under 510(k) number K042816. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRAUMACAD 1.2?

TRAUMACAD 1.2 is a medical device that received FDA 510(k) clearance on 2004-11-10. The listed applicant is Orthocrat, Ltd.. The 510(k) number is K042816.

When did TRAUMACAD 1.2 receive FDA 510(k) clearance?

TRAUMACAD 1.2 received FDA 510(k) clearance on 2004-11-10, under 510(k) number K042816.

Who is the listed applicant for TRAUMACAD 1.2?

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

What is the FDA product code for TRAUMACAD 1.2?

The FDA product code for TRAUMACAD 1.2 is LLZ.

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.

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Other records listing Orthocrat, Ltd. 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.

K073714TRAUMACAD VERSION 2.0

Related Devices (Code: LLZ)

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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