FDA 510(k)

OOOPDS

K-Number: K254214 · 2026-09-15

ApplicantTaiwan Main Orthopaedic Biotechnology Co., Ltd.

Decision Date2026-09-15

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

OOOPDS 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 2026-09-15 under 510(k) number K254214. 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 OOOPDS?

OOOPDS is a medical device that received FDA 510(k) clearance on 2026-09-15. The listed applicant is Taiwan Main Orthopaedic Biotechnology Co., Ltd.. The 510(k) number is K254214.

When did OOOPDS receive FDA 510(k) clearance?

OOOPDS received FDA 510(k) clearance on 2026-09-15, under 510(k) number K254214.

Who is the listed applicant for OOOPDS?

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 OOOPDS?

The FDA product code for OOOPDS is LLZ.

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.

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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.