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FDA 510(k)

MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL

K-Number: K012350 · 2002-03-14

ApplicantPorex Surgical, Inc.
Decision Date2002-03-14
Product CodeFWP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL 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 2002-03-14 under 510(k) number K012350. The device is classified under product code FWP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL?

MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL is a medical device that received FDA 510(k) clearance on 2002-03-14. The listed applicant is Porex Surgical, Inc.. The 510(k) number is K012350.

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

MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL received FDA 510(k) clearance on 2002-03-14, under 510(k) number K012350.

Who is the listed applicant for MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL?

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 PLUS SURGICAL IMPLANT BIOMATERIAL?

The FDA product code for MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL is FWP.

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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 IMPLANTK083621MEDPOR CUSTOMIZED SURGICAL IMPLANTK071335MEDPOR ATTRACTOR IMPLANT

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Related Devices (Code: FWP)

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.

K254233MEDPOR Customized Implant KitStryker Leibinger GmbH & Co KGK232593FITme Customized Silicone ImplantKeosan Trading Co.K200610Customized Contour ImplantImplantech Associates, Inc.K191130Customized Contour ImplantImplantech Associates, Inc.K191916Stryker CMF MEDPOR Priority Customized Implant KitStryker Leibinger GmbH & Co KGK153508Stryker CMF MEDPOR Customized ImplantStryker

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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