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FDA 510(k)

PACP SYSTEM

K-Number: K053053 · 2005-11-16

ApplicantPioneer Surgical Technology
Decision Date2005-11-16
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PACP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pioneer Surgical Technology. It received FDA 510(k) clearance on 2005-11-16 under 510(k) number K053053. 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 PACP SYSTEM?

PACP SYSTEM is a medical device that received FDA 510(k) clearance on 2005-11-16. The listed applicant is Pioneer Surgical Technology. The 510(k) number is K053053.

When did PACP SYSTEM receive FDA 510(k) clearance?

PACP SYSTEM received FDA 510(k) clearance on 2005-11-16, under 510(k) number K053053.

Who is the listed applicant for PACP SYSTEM?

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

What is the FDA product code for PACP SYSTEM?

The FDA product code for PACP SYSTEM is KWQ.

Related Clinical Trials

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.

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Other records listing Pioneer Surgical Technology 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.

K110561FORTROSS BONE VOID FILLERK101790QUANTUM SPINAL SYSTEM, QUANTUM MISK101525PIONEER SPINOUS PROCESS FUSION PLATEK093692QUANTUM/ STREAMLINE SPINAL SYSTEM MODEL 02-SERIES AND 10-SERIESK093771QUANTUM/STREAMLINE TL MIS SPINAL SYSTEMK100708PIONEER ANTERIOR CERVICAL PLATE MODEL 24-SERIES

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Related Devices (Code: KWQ)

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.

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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