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FDA 510(k)

MEDPOR FIXATION SYSTEM

K-Number: K091807 · 2010-06-28

ApplicantPorex Surgical, Inc.
Decision Date2010-06-28
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MEDPOR FIXATION SYSTEM 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 2010-06-28 under 510(k) number K091807. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDPOR FIXATION SYSTEM?

MEDPOR FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2010-06-28. The listed applicant is Porex Surgical, Inc.. The 510(k) number is K091807.

When did MEDPOR FIXATION SYSTEM receive FDA 510(k) clearance?

MEDPOR FIXATION SYSTEM received FDA 510(k) clearance on 2010-06-28, under 510(k) number K091807.

Who is the listed applicant for MEDPOR FIXATION SYSTEM?

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 FIXATION SYSTEM?

The FDA product code for MEDPOR FIXATION SYSTEM is JEY.

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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, 80079K091120MEDPOR CONTAIN IMPLANTK083621MEDPOR CUSTOMIZED SURGICAL IMPLANTK071335MEDPOR ATTRACTOR IMPLANTK052297POREX ELECTROSURGERY NEEDLE

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Related Devices (Code: JEY)

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.

K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient SolutionsKLS-Martin L.P.K253206METICULY Patient-specific CMF solutionMeticuly Co., Ltd.K252246Leforte MMF SystemJeil Medical CorporationK253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty) , Ltd.K251441Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation SystemInion OYK241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P.

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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