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FDA 510(k)

MACROPORE OS TRAUMA

K-Number: K021164 · 2002-07-01

ApplicantMacropore Biosurgery, Inc.
Decision Date2002-07-01
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MACROPORE OS TRAUMA is the device name listed in this FDA 510(k) record. The listed applicant is Macropore Biosurgery, Inc.. It received FDA 510(k) clearance on 2002-07-01 under 510(k) number K021164. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MACROPORE OS TRAUMA?

MACROPORE OS TRAUMA is a medical device that received FDA 510(k) clearance on 2002-07-01. The listed applicant is Macropore Biosurgery, Inc.. The 510(k) number is K021164.

When did MACROPORE OS TRAUMA receive FDA 510(k) clearance?

MACROPORE OS TRAUMA received FDA 510(k) clearance on 2002-07-01, under 510(k) number K021164.

Who is the listed applicant for MACROPORE OS TRAUMA?

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

What is the FDA product code for MACROPORE OS TRAUMA?

The FDA product code for MACROPORE OS TRAUMA is HRS.

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Other records listing Macropore Biosurgery, 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: HRS)

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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