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FDA 510(k)

ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL INSTRUMENTATION SYSTEM

K-Number: K934044 · 1994-03-10

ApplicantSmith and Nephew Donjoy, Inc.
Decision Date1994-03-10
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL INSTRUMENTATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Smith and Nephew Donjoy, Inc.. It received FDA 510(k) clearance on 1994-03-10 under 510(k) number K934044. 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) SURGICAL INSTRUMENTATION SYSTEM?

ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL INSTRUMENTATION SYSTEM is a medical device that received FDA 510(k) clearance on 1994-03-10. The listed applicant is Smith and Nephew Donjoy, Inc.. The 510(k) number is K934044.

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

ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL INSTRUMENTATION SYSTEM received FDA 510(k) clearance on 1994-03-10, under 510(k) number K934044.

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

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

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

The FDA product code for ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL INSTRUMENTATION 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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