FDA 510(k)

CANNULATED SMARTSCREW MODELS 224540C, 224570C

K-Number: K992947 · 1999-09-21

Decision Date1999-09-21

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

CANNULATED SMARTSCREW MODELS 224540C, 224570C is the device name listed in this FDA 510(k) record. The listed applicant is Bionx Implants, Ltd.. It received FDA 510(k) clearance on 1999-09-21 under 510(k) number K992947. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CANNULATED SMARTSCREW MODELS 224540C, 224570C?

CANNULATED SMARTSCREW MODELS 224540C, 224570C is a medical device that received FDA 510(k) clearance on 1999-09-21. The listed applicant is Bionx Implants, Ltd.. The 510(k) number is K992947.

When did CANNULATED SMARTSCREW MODELS 224540C, 224570C receive FDA 510(k) clearance?

CANNULATED SMARTSCREW MODELS 224540C, 224570C received FDA 510(k) clearance on 1999-09-21, under 510(k) number K992947.

Who is the listed applicant for CANNULATED SMARTSCREW MODELS 224540C, 224570C?

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

What is the FDA product code for CANNULATED SMARTSCREW MODELS 224540C, 224570C?

The FDA product code for CANNULATED SMARTSCREW MODELS 224540C, 224570C is HWC. This falls under the Cardiovascular category.

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Other records listing Bionx Implants, Ltd. as applicant

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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.