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FDA 510(k)

AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT

K-Number: K080507 · 2008-04-21

ApplicantCeremed , Inc.
Decision Date2008-04-21
Product CodeKKY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Ceremed , Inc.. It received FDA 510(k) clearance on 2008-04-21 under 510(k) number K080507. The device is classified under product code KKY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT?

AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT is a medical device that received FDA 510(k) clearance on 2008-04-21. The listed applicant is Ceremed , Inc.. The 510(k) number is K080507.

When did AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT receive FDA 510(k) clearance?

AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT received FDA 510(k) clearance on 2008-04-21, under 510(k) number K080507.

Who is the listed applicant for AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT?

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

What is the FDA product code for AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT?

The FDA product code for AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT is KKY.

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Other records listing Ceremed , 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.

K161446Biopor Porous Polyethylene ImplantsK160988Biopor, AOC Porous Polyethylene, CereporK132198ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAIK122561ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAINK120220ADAPTAIN SOLUBLE IMPLANT MATERIALK103047CERETENE SOLUBLE IMPLANT MATERIAL

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Related Devices (Code: KKY)

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.

K211514Longeviti PorousFit implantLongeviti Neuro Solutions, LLCK161052OsteoFab Patient Specific Facial DeviceOxford Performance Materials, Inc.K160988Biopor, AOC Porous Polyethylene, CereporCeremed , Inc.K123908OMNIPORE SURGICAL IMPLANTS AND ACCESSORIESMatrix Surgical USAK111323SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTSSynthes, Inc.K103010STRYKER PATIENT SPECIFIC POLYMER IMPLANTHowmedica Osteonics Corp., Dba Stryker Orthopaedics

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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