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FDA 510(k)

Caduceus S

K-Number: K220554 · 2022-12-16

Decision Date2022-12-16
Product CodeSBF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Caduceus S is the device name listed in this FDA 510(k) record. The listed applicant is Taiwan Main Orthopaedic Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2022-12-16 under 510(k) number K220554. The device is classified under product code SBF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Caduceus S?

Caduceus S is a medical device that received FDA 510(k) clearance on 2022-12-16. The listed applicant is Taiwan Main Orthopaedic Biotechnology Co., Ltd.. The 510(k) number is K220554.

When did Caduceus S receive FDA 510(k) clearance?

Caduceus S received FDA 510(k) clearance on 2022-12-16, under 510(k) number K220554.

Who is the listed applicant for Caduceus S?

The FDA 510(k) record lists Taiwan Main Orthopaedic Biotechnology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Caduceus S?

The FDA product code for Caduceus S is SBF.

Other records listing Taiwan Main Orthopaedic Biotechnology Co., 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.

Related Devices (Code: SBF)

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.