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FDA 510(k)

ACE CANCELLOUS BONE SCREW

K-Number: K882831 · 1988-08-01

ApplicantBuckman Co., Inc.
Decision Date1988-08-01
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACE CANCELLOUS BONE 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 1988-08-01 under 510(k) number K882831. 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 CANCELLOUS BONE SCREW?

ACE CANCELLOUS BONE SCREW is a medical device that received FDA 510(k) clearance on 1988-08-01. The listed applicant is Buckman Co., Inc.. The 510(k) number is K882831.

When did ACE CANCELLOUS BONE SCREW receive FDA 510(k) clearance?

ACE CANCELLOUS BONE SCREW received FDA 510(k) clearance on 1988-08-01, under 510(k) number K882831.

Who is the listed applicant for ACE CANCELLOUS BONE 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 CANCELLOUS BONE SCREW?

The FDA product code for ACE CANCELLOUS BONE SCREW is HWC. This falls under the Cardiovascular category.

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Other records listing Buckman Co., Inc. as applicant

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Related Devices (Code: HWC)

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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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