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FDA 510(k)

MEDPOR CUSTOMIZED SURGICAL IMPLANT

K-Number: K083621 · 2009-02-03

ApplicantPorex Surgical, Inc.
Decision Date2009-02-03
Product CodeJOF
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MEDPOR CUSTOMIZED SURGICAL IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Porex Surgical, Inc.. It received FDA 510(k) clearance on 2009-02-03 under 510(k) number K083621. The device is classified under product code JOF. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDPOR CUSTOMIZED SURGICAL IMPLANT?

MEDPOR CUSTOMIZED SURGICAL IMPLANT is a medical device that received FDA 510(k) clearance on 2009-02-03. The listed applicant is Porex Surgical, Inc.. The 510(k) number is K083621.

When did MEDPOR CUSTOMIZED SURGICAL IMPLANT receive FDA 510(k) clearance?

MEDPOR CUSTOMIZED SURGICAL IMPLANT received FDA 510(k) clearance on 2009-02-03, under 510(k) number K083621.

Who is the listed applicant for MEDPOR CUSTOMIZED SURGICAL IMPLANT?

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

What is the FDA product code for MEDPOR CUSTOMIZED SURGICAL IMPLANT?

The FDA product code for MEDPOR CUSTOMIZED SURGICAL IMPLANT is JOF.

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Other records listing Porex Surgical, 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.

K102184MEDPOR CONTAIN CAN IMPLANTK101835MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079K091807MEDPOR FIXATION SYSTEMK091120MEDPOR CONTAIN IMPLANTK071335MEDPOR ATTRACTOR IMPLANTK052297POREX ELECTROSURGERY NEEDLE

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Related Devices (Code: JOF)

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.

K200532StarPoreAnatomics Pty, Ltd.K171037PoreStar Patient Specific ImplantAnatomics Pty, Ltd.K002629SILMAX CONTOUR CARVING BLOCK IMPLANTPillar Surgical, Inc.K771727BIOSPONGE RECONSTRUCTION DISCSXomed, Inc.K771726BIOSPONGE STAPES PISTONXomed, Inc.

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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