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FDA 510(k)

QUANTUM-MIS CANNULATED SYSTEM

K-Number: K080026 · 2008-01-28

ApplicantPioneer Surgical Technology
Decision Date2008-01-28
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

QUANTUM-MIS CANNULATED 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 2008-01-28 under 510(k) number K080026. The device is classified under product code MNI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTUM-MIS CANNULATED SYSTEM?

QUANTUM-MIS CANNULATED SYSTEM is a medical device that received FDA 510(k) clearance on 2008-01-28. The listed applicant is Pioneer Surgical Technology. The 510(k) number is K080026.

When did QUANTUM-MIS CANNULATED SYSTEM receive FDA 510(k) clearance?

QUANTUM-MIS CANNULATED SYSTEM received FDA 510(k) clearance on 2008-01-28, under 510(k) number K080026.

Who is the listed applicant for QUANTUM-MIS CANNULATED 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 QUANTUM-MIS CANNULATED SYSTEM?

The FDA product code for QUANTUM-MIS CANNULATED SYSTEM is MNI.

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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: MNI)

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.

K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co. , Ltd.K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd.K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc.K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.K160320PremierShandong Weigao Orthopaedic Device Co., Ltd.

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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