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FDA 510(k)

ACE CORTICAL LAG SCREW

K-Number: K874672 · 1987-12-11

ApplicantBuckman Co., Inc.
Decision Date1987-12-11
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACE CORTICAL LAG SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Buckman Co., Inc.. It received FDA 510(k) clearance on 1987-12-11 under 510(k) number K874672. 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 ACE CORTICAL LAG SCREW?

ACE CORTICAL LAG SCREW is a medical device that received FDA 510(k) clearance on 1987-12-11. The listed applicant is Buckman Co., Inc.. The 510(k) number is K874672.

When did ACE CORTICAL LAG SCREW receive FDA 510(k) clearance?

ACE CORTICAL LAG SCREW received FDA 510(k) clearance on 1987-12-11, under 510(k) number K874672.

Who is the listed applicant for ACE CORTICAL LAG SCREW?

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

What is the FDA product code for ACE CORTICAL LAG SCREW?

The FDA product code for ACE CORTICAL LAG 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.

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