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FDA 510(k)

WISORB MALLEOLAR SCREW

K-Number: K020222 · 2002-07-29

ApplicantCambridge Scientific, Inc.
Decision Date2002-07-29
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

WISORB MALLEOLAR SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Cambridge Scientific, Inc.. It received FDA 510(k) clearance on 2002-07-29 under 510(k) number K020222. 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 WISORB MALLEOLAR SCREW?

WISORB MALLEOLAR SCREW is a medical device that received FDA 510(k) clearance on 2002-07-29. The listed applicant is Cambridge Scientific, Inc.. The 510(k) number is K020222.

When did WISORB MALLEOLAR SCREW receive FDA 510(k) clearance?

WISORB MALLEOLAR SCREW received FDA 510(k) clearance on 2002-07-29, under 510(k) number K020222.

Who is the listed applicant for WISORB MALLEOLAR SCREW?

The FDA 510(k) record lists Cambridge Scientific, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WISORB MALLEOLAR SCREW?

The FDA product code for WISORB MALLEOLAR SCREW is HWC. This falls under the Cardiovascular category.

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Related Devices (Code: HWC)

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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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