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FDA 510(k)

PROLIXUS TOTAL KNEE SYSTEM

K-Number: K170534 · 2017-11-09

ApplicantOtis Biotech Co., Ltd.
Decision Date2017-11-09
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PROLIXUS TOTAL KNEE SYSTEM is a medical device manufactured by Otis Biotech Co., Ltd.. It received FDA 510(k) clearance on 2017-11-09 under approval number K170534. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROLIXUS TOTAL KNEE SYSTEM?

PROLIXUS TOTAL KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 2017-11-09. It is manufactured by Otis Biotech Co., Ltd.. The 510(k) number is K170534.

When was PROLIXUS TOTAL KNEE SYSTEM approved by the FDA?

PROLIXUS TOTAL KNEE SYSTEM received FDA 510(k) clearance on 2017-11-09, under approval number K170534.

What company makes PROLIXUS TOTAL KNEE SYSTEM?

PROLIXUS TOTAL KNEE SYSTEM is manufactured by Otis Biotech Co., Ltd..

What is the FDA product code for PROLIXUS TOTAL KNEE SYSTEM?

The FDA product code for PROLIXUS TOTAL KNEE SYSTEM is JWH.

Related Clinical Trials

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Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026)

Related Devices (Code: JWH)

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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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