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FDA 510(k)

BIO-INTERFERENCE SCREW

K-Number: K990454 · 1999-07-01

ApplicantInnovasive Devices, Inc.
Decision Date1999-07-01
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIO-INTERFERENCE SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Innovasive Devices, Inc.. It received FDA 510(k) clearance on 1999-07-01 under 510(k) number K990454. 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 BIO-INTERFERENCE SCREW?

BIO-INTERFERENCE SCREW is a medical device that received FDA 510(k) clearance on 1999-07-01. The listed applicant is Innovasive Devices, Inc.. The 510(k) number is K990454.

When did BIO-INTERFERENCE SCREW receive FDA 510(k) clearance?

BIO-INTERFERENCE SCREW received FDA 510(k) clearance on 1999-07-01, under 510(k) number K990454.

Who is the listed applicant for BIO-INTERFERENCE SCREW?

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

What is the FDA product code for BIO-INTERFERENCE SCREW?

The FDA product code for BIO-INTERFERENCE SCREW is HWC. This falls under the Cardiovascular category.

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Other records listing Innovasive Devices, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K994269TITAN RC TACKK993975ABSOLUTE ABSORBABLE INTERFERENCE SCREWK992458RC MULTISUTURE BONE ANCHOR, MODEL 4453/4454K992377RC TACKK984490SUTURELESS ANCHORK983560INNOVASIVE DEVICES INTRATUNNEL TIBIAL FIXATION FASTENER

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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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