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FDA 510(k)

ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM

K-Number: K011102 · 2001-08-03

ApplicantAesculap, Inc.
Decision Date2001-08-03
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap, Inc.. It received FDA 510(k) clearance on 2001-08-03 under 510(k) number K011102. 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 ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM?

ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2001-08-03. The listed applicant is Aesculap, Inc.. The 510(k) number is K011102.

When did ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM receive FDA 510(k) clearance?

ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM received FDA 510(k) clearance on 2001-08-03, under 510(k) number K011102.

Who is the listed applicant for ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM?

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

What is the FDA product code for ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM?

The FDA product code for ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM is HWC. This falls under the Cardiovascular category.

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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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