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FDA 510(k)

INNOVASIVE DEVICES ROTATOR CUFF FASTENER

K-Number: K951565 · 1995-09-08

ApplicantInnovasive Devices, Inc.
Decision Date1995-09-08
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INNOVASIVE DEVICES ROTATOR CUFF FASTENER 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 1995-09-08 under 510(k) number K951565. 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 FASTENER?

INNOVASIVE DEVICES ROTATOR CUFF FASTENER is a medical device that received FDA 510(k) clearance on 1995-09-08. The listed applicant is Innovasive Devices, Inc.. The 510(k) number is K951565.

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

INNOVASIVE DEVICES ROTATOR CUFF FASTENER received FDA 510(k) clearance on 1995-09-08, under 510(k) number K951565.

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

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 FASTENER?

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

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Other records listing Innovasive Devices, Inc. as applicant

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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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