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FDA 510(k)

TOWNLEY PEDICLE SCREW PLATING SYSTEM

K-Number: K970599 · 1998-03-20

ApplicantDanek Medical, Inc.
Decision Date1998-03-20
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TOWNLEY PEDICLE SCREW PLATING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Danek Medical, Inc.. It received FDA 510(k) clearance on 1998-03-20 under 510(k) number K970599. 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 TOWNLEY PEDICLE SCREW PLATING SYSTEM?

TOWNLEY PEDICLE SCREW PLATING SYSTEM is a medical device that received FDA 510(k) clearance on 1998-03-20. The listed applicant is Danek Medical, Inc.. The 510(k) number is K970599.

When did TOWNLEY PEDICLE SCREW PLATING SYSTEM receive FDA 510(k) clearance?

TOWNLEY PEDICLE SCREW PLATING SYSTEM received FDA 510(k) clearance on 1998-03-20, under 510(k) number K970599.

Who is the listed applicant for TOWNLEY PEDICLE SCREW PLATING SYSTEM?

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

What is the FDA product code for TOWNLEY PEDICLE SCREW PLATING SYSTEM?

The FDA product code for TOWNLEY PEDICLE SCREW PLATING SYSTEM is MNI.

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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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