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FDA 510(k)

AIMS CANNULATED ACL SCREW (7MM DIAMETER)

K-Number: K945236 · 1995-02-03

ApplicantSmith and Nephew Donjoy, Inc.
Decision Date1995-02-03
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AIMS CANNULATED ACL SCREW (7MM DIAMETER) 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 1995-02-03 under 510(k) number K945236. 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 AIMS CANNULATED ACL SCREW (7MM DIAMETER)?

AIMS CANNULATED ACL SCREW (7MM DIAMETER) is a medical device that received FDA 510(k) clearance on 1995-02-03. The listed applicant is Smith and Nephew Donjoy, Inc.. The 510(k) number is K945236.

When did AIMS CANNULATED ACL SCREW (7MM DIAMETER) receive FDA 510(k) clearance?

AIMS CANNULATED ACL SCREW (7MM DIAMETER) received FDA 510(k) clearance on 1995-02-03, under 510(k) number K945236.

Who is the listed applicant for AIMS CANNULATED ACL SCREW (7MM DIAMETER)?

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 AIMS CANNULATED ACL SCREW (7MM DIAMETER)?

The FDA product code for AIMS CANNULATED ACL SCREW (7MM DIAMETER) 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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