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FDA 510(k)

INNOVASIVE DEVICES ROTATOR CUFF FASTNER

K-Number: K964945 · 1997-02-24

ApplicantInnovasive Devices, Inc.
Decision Date1997-02-24
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INNOVASIVE DEVICES ROTATOR CUFF FASTNER 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 1997-02-24 under 510(k) number K964945. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INNOVASIVE DEVICES ROTATOR CUFF FASTNER?

INNOVASIVE DEVICES ROTATOR CUFF FASTNER is a medical device that received FDA 510(k) clearance on 1997-02-24. The listed applicant is Innovasive Devices, Inc.. The 510(k) number is K964945.

When did INNOVASIVE DEVICES ROTATOR CUFF FASTNER receive FDA 510(k) clearance?

INNOVASIVE DEVICES ROTATOR CUFF FASTNER received FDA 510(k) clearance on 1997-02-24, under 510(k) number K964945.

Who is the listed applicant for INNOVASIVE DEVICES ROTATOR CUFF FASTNER?

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 ROTATOR CUFF FASTNER?

The FDA product code for INNOVASIVE DEVICES ROTATOR CUFF FASTNER is MBI.

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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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Related Devices (Code: MBI)

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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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