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FDA 510(k)

USS-LINE EXTENSION

K-Number: K010108 · 2001-06-06

ApplicantSynthes
Decision Date2001-06-06
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

USS-LINE EXTENSION is the device name listed in this FDA 510(k) record. The listed applicant is Synthes. It received FDA 510(k) clearance on 2001-06-06 under 510(k) number K010108. 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 USS-LINE EXTENSION?

USS-LINE EXTENSION is a medical device that received FDA 510(k) clearance on 2001-06-06. The listed applicant is Synthes. The 510(k) number is K010108.

When did USS-LINE EXTENSION receive FDA 510(k) clearance?

USS-LINE EXTENSION received FDA 510(k) clearance on 2001-06-06, under 510(k) number K010108.

Who is the listed applicant for USS-LINE EXTENSION?

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

What is the FDA product code for USS-LINE EXTENSION?

The FDA product code for USS-LINE EXTENSION is MNI.

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Other records listing Synthes as applicant

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K123723SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEMK122455SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEMK113071SYNTHECEL DURA REPLACEMENT DEVICESK110604VBB SYSTEMK093772SYNTHES STERNAL FIXATION SYSTEMK013072CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP)

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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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