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FDA 510(k)

MODIFICATION TO TOWNLEY PEDICLE SCREW PLATING SYSTEM

K-Number: K982686 · 1998-08-07

ApplicantSofamor Danek USA,Inc.
Decision Date1998-08-07
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO TOWNLEY PEDICLE SCREW PLATING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sofamor Danek USA,Inc.. It received FDA 510(k) clearance on 1998-08-07 under 510(k) number K982686. 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 MODIFICATION TO TOWNLEY PEDICLE SCREW PLATING SYSTEM?

MODIFICATION TO TOWNLEY PEDICLE SCREW PLATING SYSTEM is a medical device that received FDA 510(k) clearance on 1998-08-07. The listed applicant is Sofamor Danek USA,Inc.. The 510(k) number is K982686.

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

MODIFICATION TO TOWNLEY PEDICLE SCREW PLATING SYSTEM received FDA 510(k) clearance on 1998-08-07, under 510(k) number K982686.

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

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

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

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

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Other records listing Sofamor Danek USA,Inc. as applicant

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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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