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FDA 510(k)

PIONEER ASPECT ANTERIOR CERVICAL PLATE SYSTEM

K-Number: K130427 · 2013-06-05

ApplicantPioneer Surgical Technology, Inc.
Decision Date2013-06-05
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PIONEER ASPECT ANTERIOR CERVICAL PLATE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pioneer Surgical Technology, Inc.. It received FDA 510(k) clearance on 2013-06-05 under 510(k) number K130427. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PIONEER ASPECT ANTERIOR CERVICAL PLATE SYSTEM?

PIONEER ASPECT ANTERIOR CERVICAL PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 2013-06-05. The listed applicant is Pioneer Surgical Technology, Inc.. The 510(k) number is K130427.

When did PIONEER ASPECT ANTERIOR CERVICAL PLATE SYSTEM receive FDA 510(k) clearance?

PIONEER ASPECT ANTERIOR CERVICAL PLATE SYSTEM received FDA 510(k) clearance on 2013-06-05, under 510(k) number K130427.

Who is the listed applicant for PIONEER ASPECT ANTERIOR CERVICAL PLATE SYSTEM?

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

What is the FDA product code for PIONEER ASPECT ANTERIOR CERVICAL PLATE SYSTEM?

The FDA product code for PIONEER ASPECT ANTERIOR CERVICAL PLATE SYSTEM is KWQ.

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Other records listing Pioneer Surgical Technology, Inc. as applicant

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K261271Cable-Ready® Cable Grip SystemK251436Resolve Anterior Cervical Plate SystemK222493CODA™ Anterior Cervical Plate SystemK211408CervAlign® Anterior Cervical Plate SystemK192396Streamline MIS Spinal Fixation SystemK131724PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE

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Related Devices (Code: KWQ)

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K262149corra® cervical plating systemCarlsmed, Inc.K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLCK252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, 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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