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FDA 510(k)

INNOVASIVE DEVICES MENISCAL SCREW

K-Number: K980681 · 1998-04-29

ApplicantInnovasive Devices, Inc.
Decision Date1998-04-29
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INNOVASIVE DEVICES MENISCAL 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 1998-04-29 under 510(k) number K980681. 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 INNOVASIVE DEVICES MENISCAL SCREW?

INNOVASIVE DEVICES MENISCAL SCREW is a medical device that received FDA 510(k) clearance on 1998-04-29. The listed applicant is Innovasive Devices, Inc.. The 510(k) number is K980681.

When did INNOVASIVE DEVICES MENISCAL SCREW receive FDA 510(k) clearance?

INNOVASIVE DEVICES MENISCAL SCREW received FDA 510(k) clearance on 1998-04-29, under 510(k) number K980681.

Who is the listed applicant for INNOVASIVE DEVICES MENISCAL 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 INNOVASIVE DEVICES MENISCAL SCREW?

The FDA product code for INNOVASIVE DEVICES MENISCAL 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 TACKK990454BIO-INTERFERENCE SCREWK984490SUTURELESS ANCHOR

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Official Source

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