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FDA 510(k)

TITANIUM COMPRESSION ANCHOR SYSTEM

K-Number: K010884 · 2001-06-20

ApplicantAnchor Medical Technologies
Decision Date2001-06-20
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TITANIUM COMPRESSION ANCHOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Anchor Medical Technologies. It received FDA 510(k) clearance on 2001-06-20 under 510(k) number K010884. 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 TITANIUM COMPRESSION ANCHOR SYSTEM?

TITANIUM COMPRESSION ANCHOR SYSTEM is a medical device that received FDA 510(k) clearance on 2001-06-20. The listed applicant is Anchor Medical Technologies. The 510(k) number is K010884.

When did TITANIUM COMPRESSION ANCHOR SYSTEM receive FDA 510(k) clearance?

TITANIUM COMPRESSION ANCHOR SYSTEM received FDA 510(k) clearance on 2001-06-20, under 510(k) number K010884.

Who is the listed applicant for TITANIUM COMPRESSION ANCHOR SYSTEM?

The FDA 510(k) record lists Anchor Medical Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TITANIUM COMPRESSION ANCHOR SYSTEM?

The FDA product code for TITANIUM COMPRESSION ANCHOR SYSTEM 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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