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FDA 510(k)

INNOVASIVE DEVICES MENISCAL DART REPAIR SYSTEM

K-Number: K981340 · 1998-06-22

ApplicantInnovasive Devices, Inc.
Decision Date1998-06-22
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INNOVASIVE DEVICES MENISCAL DART REPAIR SYSTEM 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 1998-06-22 under 510(k) number K981340. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INNOVASIVE DEVICES MENISCAL DART REPAIR SYSTEM?

INNOVASIVE DEVICES MENISCAL DART REPAIR SYSTEM is a medical device that received FDA 510(k) clearance on 1998-06-22. The listed applicant is Innovasive Devices, Inc.. The 510(k) number is K981340.

When did INNOVASIVE DEVICES MENISCAL DART REPAIR SYSTEM receive FDA 510(k) clearance?

INNOVASIVE DEVICES MENISCAL DART REPAIR SYSTEM received FDA 510(k) clearance on 1998-06-22, under 510(k) number K981340.

Who is the listed applicant for INNOVASIVE DEVICES MENISCAL DART REPAIR SYSTEM?

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 DART REPAIR SYSTEM?

The FDA product code for INNOVASIVE DEVICES MENISCAL DART REPAIR SYSTEM is MAI.

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Other records listing Innovasive Devices, Inc. as applicant

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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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