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FDA 510(k)

EXACTECH BONE SCREW

K-Number: K896601 · 1989-12-06

ApplicantExactech, Inc.
Decision Date1989-12-06
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXACTECH BONE SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 1989-12-06 under 510(k) number K896601. 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 EXACTECH BONE SCREW?

EXACTECH BONE SCREW is a medical device that received FDA 510(k) clearance on 1989-12-06. The listed applicant is Exactech, Inc.. The 510(k) number is K896601.

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

EXACTECH BONE SCREW received FDA 510(k) clearance on 1989-12-06, under 510(k) number K896601.

Who is the listed applicant for EXACTECH BONE SCREW?

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

What is the FDA product code for EXACTECH BONE SCREW?

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

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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