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FDA 510(k)

BIOAGGREGATE

K-Number: K063422 · 2006-11-21

ApplicantInnovative Bioceramix, Inc.
Decision Date2006-11-21
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIOAGGREGATE is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Bioceramix, Inc.. It received FDA 510(k) clearance on 2006-11-21 under 510(k) number K063422. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOAGGREGATE?

BIOAGGREGATE is a medical device that received FDA 510(k) clearance on 2006-11-21. The listed applicant is Innovative Bioceramix, Inc.. The 510(k) number is K063422.

When did BIOAGGREGATE receive FDA 510(k) clearance?

BIOAGGREGATE received FDA 510(k) clearance on 2006-11-21, under 510(k) number K063422.

Who is the listed applicant for BIOAGGREGATE?

The FDA 510(k) record lists Innovative Bioceramix, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOAGGREGATE?

The FDA product code for BIOAGGREGATE is KIF.

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Other records listing Innovative Bioceramix, Inc. as applicant

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Related Devices (Code: KIF)

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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