FDA 510(k)

AIMS CANNULATED ACL SCREW

K-Number: K943539 · 1994-10-19

Decision Date1994-10-19

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

AIMS CANNULATED ACL SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 1994-10-19 under 510(k) number K943539. 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?

AIMS CANNULATED ACL SCREW is a medical device that received FDA 510(k) clearance on 1994-10-19. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K943539.

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

AIMS CANNULATED ACL SCREW received FDA 510(k) clearance on 1994-10-19, under 510(k) number K943539.

Who is the listed applicant for AIMS CANNULATED ACL SCREW?

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

What is the FDA product code for AIMS CANNULATED ACL SCREW?

The FDA product code for AIMS CANNULATED ACL SCREW 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.