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FDA 510(k)

MACROPORE HYDROSORB SPINE SYSTEM

K-Number: K041105 · 2004-07-28

ApplicantMacropore Biosurgery, Inc.
Decision Date2004-07-28
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MACROPORE HYDROSORB SPINE SYSTEM 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 2004-07-28 under 510(k) number K041105. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MACROPORE HYDROSORB SPINE SYSTEM?

MACROPORE HYDROSORB SPINE SYSTEM is a medical device that received FDA 510(k) clearance on 2004-07-28. The listed applicant is Macropore Biosurgery, Inc.. The 510(k) number is K041105.

When did MACROPORE HYDROSORB SPINE SYSTEM receive FDA 510(k) clearance?

MACROPORE HYDROSORB SPINE SYSTEM received FDA 510(k) clearance on 2004-07-28, under 510(k) number K041105.

Who is the listed applicant for MACROPORE HYDROSORB SPINE SYSTEM?

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 HYDROSORB SPINE SYSTEM?

The FDA product code for MACROPORE HYDROSORB SPINE SYSTEM is KWQ.

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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.

K042261MACROPORE PURICEL LIPOPLASTY SYSTEMK031955MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEETK031785MACROPORE CARDIO-WRAP (TS)K024169MACROPORE OS RECONSTRUCTIONK023643MACROPORE SURGICAL BARRIER FILMK021164MACROPORE OS TRAUMA

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Related Devices (Code: KWQ)

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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