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FDA 510(k)

SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS

K-Number: K111323 · 2011-11-16

ApplicantSynthes, Inc.
Decision Date2011-11-16
Product CodeKKY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS is the device name listed in this FDA 510(k) record. The listed applicant is Synthes, Inc.. It received FDA 510(k) clearance on 2011-11-16 under 510(k) number K111323. 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 SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS?

SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS is a medical device that received FDA 510(k) clearance on 2011-11-16. The listed applicant is Synthes, Inc.. The 510(k) number is K111323.

When did SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS receive FDA 510(k) clearance?

SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS received FDA 510(k) clearance on 2011-11-16, under 510(k) number K111323.

Who is the listed applicant for SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS?

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

What is the FDA product code for SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS?

The FDA product code for SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS is KKY.

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Other records listing Synthes, 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.

K131792SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAYK122647SYNTHES PATIENT SPECIFIC PLATEK113567SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEMK121502SYNTHES CURVILINEAR DISTRACTION SYSTEMK121574SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEMK113251SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATES

View all 8 devices →

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 USAK103010STRYKER PATIENT SPECIFIC POLYMER IMPLANTHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK080507AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANTCeremed , 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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