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FDA 510(k)

BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP

K-Number: K112019 · 2011-10-12

Decision Date2011-10-12
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP 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 2011-10-12 under 510(k) number K112019. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP?

BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP is a medical device that received FDA 510(k) clearance on 2011-10-12. The listed applicant is Corentec Co., Ltd.. The 510(k) number is K112019.

When did BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP receive FDA 510(k) clearance?

BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP received FDA 510(k) clearance on 2011-10-12, under 510(k) number K112019.

Who is the listed applicant for BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP?

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 BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP?

The FDA product code for BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP is KWY.

Related Clinical Trials

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.

Other records listing Corentec 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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Related Devices (Code: KWY)

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.

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