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FDA 510(k)

BIOROC EZ SUTURE BONE FASTENER

K-Number: K973381 · 1998-02-18

ApplicantInnovasive Devices, Inc.
Decision Date1998-02-18
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOROC EZ SUTURE BONE 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 1998-02-18 under 510(k) number K973381. 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 BIOROC EZ SUTURE BONE FASTENER?

BIOROC EZ SUTURE BONE FASTENER is a medical device that received FDA 510(k) clearance on 1998-02-18. The listed applicant is Innovasive Devices, Inc.. The 510(k) number is K973381.

When did BIOROC EZ SUTURE BONE FASTENER receive FDA 510(k) clearance?

BIOROC EZ SUTURE BONE FASTENER received FDA 510(k) clearance on 1998-02-18, under 510(k) number K973381.

Who is the listed applicant for BIOROC EZ SUTURE BONE 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 BIOROC EZ SUTURE BONE FASTENER?

The FDA product code for BIOROC EZ SUTURE BONE FASTENER is MAI.

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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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