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FDA 510(k)

RESORBABLE SCREW ANCHOR

K-Number: K012872 · 2001-11-20

ApplicantArthrotek, Inc.
Decision Date2001-11-20
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RESORBABLE SCREW ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is Arthrotek, Inc.. It received FDA 510(k) clearance on 2001-11-20 under 510(k) number K012872. 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 RESORBABLE SCREW ANCHOR?

RESORBABLE SCREW ANCHOR is a medical device that received FDA 510(k) clearance on 2001-11-20. The listed applicant is Arthrotek, Inc.. The 510(k) number is K012872.

When did RESORBABLE SCREW ANCHOR receive FDA 510(k) clearance?

RESORBABLE SCREW ANCHOR received FDA 510(k) clearance on 2001-11-20, under 510(k) number K012872.

Who is the listed applicant for RESORBABLE SCREW ANCHOR?

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

What is the FDA product code for RESORBABLE SCREW ANCHOR?

The FDA product code for RESORBABLE SCREW ANCHOR is HWC. This falls under the Cardiovascular category.

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Other records listing Arthrotek, Inc. 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.

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