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FDA 510(k)

SUTURELESS ANCHOR

K-Number: K984490 · 1999-03-01

ApplicantInnovasive Devices, Inc.
Decision Date1999-03-01
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SUTURELESS ANCHOR 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 1999-03-01 under 510(k) number K984490. 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 SUTURELESS ANCHOR?

SUTURELESS ANCHOR is a medical device that received FDA 510(k) clearance on 1999-03-01. The listed applicant is Innovasive Devices, Inc.. The 510(k) number is K984490.

When did SUTURELESS ANCHOR receive FDA 510(k) clearance?

SUTURELESS ANCHOR received FDA 510(k) clearance on 1999-03-01, under 510(k) number K984490.

Who is the listed applicant for SUTURELESS ANCHOR?

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 SUTURELESS ANCHOR?

The FDA product code for SUTURELESS ANCHOR is MAI.

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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.

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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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