FDA 510(k)

LOSPA IS ACP System

K-Number: K161641 · 2017-01-05

Decision Date2017-01-05

Product CodeKWQ

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

LOSPA IS ACP System is a medical device manufactured by Corentec Co., Ltd.. It received FDA 510(k) clearance on 2017-01-05 under approval number K161641. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LOSPA IS ACP System?

LOSPA IS ACP System is a medical device that received FDA 510(k) clearance on 2017-01-05. It is manufactured by Corentec Co., Ltd.. The 510(k) number is K161641.

When was LOSPA IS ACP System approved by the FDA?

LOSPA IS ACP System received FDA 510(k) clearance on 2017-01-05, under approval number K161641.

What company makes LOSPA IS ACP System?

LOSPA IS ACP System is manufactured by Corentec Co., Ltd..

What is the FDA product code for LOSPA IS ACP System?

The FDA product code for LOSPA IS ACP System is KWQ.

Other Devices by Corentec Co., Ltd.

K162127Bencox M Stem Lateralized & Bencox Mirabo Cup System K160157LOSPA Modular Knee System K152084Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug K172806Bencox Mirabo Cup System K170243LOSPA IS TLIF & DLIF Cages K192507LOSPA II Knee System

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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.