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FDA 510(k)

LOSPA TOTAL KNEE REPLACEMENT SYSTEM

K-Number: K130673 · 2013-04-15

ApplicantCorentec Co., Ltd.
Decision Date2013-04-15
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LOSPA TOTAL KNEE REPLACEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Corentec Co., Ltd.. It received FDA 510(k) clearance on 2013-04-15 under 510(k) number K130673. 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 LOSPA TOTAL KNEE REPLACEMENT SYSTEM?

LOSPA TOTAL KNEE REPLACEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2013-04-15. The listed applicant is Corentec Co., Ltd.. The 510(k) number is K130673.

When did LOSPA TOTAL KNEE REPLACEMENT SYSTEM receive FDA 510(k) clearance?

LOSPA TOTAL KNEE REPLACEMENT SYSTEM received FDA 510(k) clearance on 2013-04-15, under 510(k) number K130673.

Who is the listed applicant for LOSPA TOTAL KNEE REPLACEMENT SYSTEM?

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

What is the FDA product code for LOSPA TOTAL KNEE REPLACEMENT SYSTEM?

The FDA product code for LOSPA TOTAL KNEE REPLACEMENT SYSTEM is JWH.

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Related Devices (Code: JWH)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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