FDA 510(k)

POSTERIOR CABLE SCREW

K-Number: K022908 · 2004-01-22

Decision Date2004-01-22

Product CodeMNI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

POSTERIOR CABLE SCREW 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 2004-01-22 under 510(k) number K022908. 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 POSTERIOR CABLE SCREW?

POSTERIOR CABLE SCREW is a medical device that received FDA 510(k) clearance on 2004-01-22. The listed applicant is Pioneer Surgical Technology. The 510(k) number is K022908.

When did POSTERIOR CABLE SCREW receive FDA 510(k) clearance?

POSTERIOR CABLE SCREW received FDA 510(k) clearance on 2004-01-22, under 510(k) number K022908.

Who is the listed applicant for POSTERIOR CABLE SCREW?

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 POSTERIOR CABLE SCREW?

The FDA product code for POSTERIOR CABLE SCREW is MNI.

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Other records listing Pioneer Surgical Technology as applicant

K110561FORTROSS BONE VOID FILLER K101790QUANTUM SPINAL SYSTEM, QUANTUM MIS K101525PIONEER SPINOUS PROCESS FUSION PLATE K093692QUANTUM/ STREAMLINE SPINAL SYSTEM MODEL 02-SERIES AND 10-SERIES K093771QUANTUM/STREAMLINE TL MIS SPINAL SYSTEM K100708PIONEER ANTERIOR CERVICAL PLATE MODEL 24-SERIES

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Related Devices (Code: MNI)

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.