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FDA 510(k)

MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT

K-Number: K021357 · 2002-08-05

ApplicantPorex Surgical, Inc.
Decision Date2002-08-05
Product CodeHPZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT 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 2002-08-05 under 510(k) number K021357. The device is classified under product code HPZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT?

MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT is a medical device that received FDA 510(k) clearance on 2002-08-05. The listed applicant is Porex Surgical, Inc.. The 510(k) number is K021357.

When did MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT receive FDA 510(k) clearance?

MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT received FDA 510(k) clearance on 2002-08-05, under 510(k) number K021357.

Who is the listed applicant for MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT?

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 ORBITAL VOLUME REPLACEMENT IMPANT?

The FDA product code for MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT is HPZ.

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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: HPZ)

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.

K212741EZYPORFci (France Chirurgie Instrumentation) SasK123764DURETTE OCULAR IMPLANTOculo-Plastik, Inc.K110554BIOCERAMIC ORBITAL IMPLANT, ORBTEXCeramisys, Ltd.K112176SILICONE SPHERESOculo Plastik, Inc.K083342ORBITAL RECONSTRUCTIVE IMPLANT IIEvera Medical, Inc.K082850EYE SPHERESProduct and Educational Services, LLC

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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