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FDA 510(k)

NEX-LINK SPINAL FIXATION SYSTEM OFFSET CONNECTORS, 2121-XX SERIES

K-Number: K062505 · 2006-09-26

ApplicantAbbott Spine, Inc.
Decision Date2006-09-26
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NEX-LINK SPINAL FIXATION SYSTEM OFFSET CONNECTORS, 2121-XX SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Spine, Inc.. It received FDA 510(k) clearance on 2006-09-26 under 510(k) number K062505. 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 NEX-LINK SPINAL FIXATION SYSTEM OFFSET CONNECTORS, 2121-XX SERIES?

NEX-LINK SPINAL FIXATION SYSTEM OFFSET CONNECTORS, 2121-XX SERIES is a medical device that received FDA 510(k) clearance on 2006-09-26. The listed applicant is Abbott Spine, Inc.. The 510(k) number is K062505.

When did NEX-LINK SPINAL FIXATION SYSTEM OFFSET CONNECTORS, 2121-XX SERIES receive FDA 510(k) clearance?

NEX-LINK SPINAL FIXATION SYSTEM OFFSET CONNECTORS, 2121-XX SERIES received FDA 510(k) clearance on 2006-09-26, under 510(k) number K062505.

Who is the listed applicant for NEX-LINK SPINAL FIXATION SYSTEM OFFSET CONNECTORS, 2121-XX SERIES?

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

What is the FDA product code for NEX-LINK SPINAL FIXATION SYSTEM OFFSET CONNECTORS, 2121-XX SERIES?

The FDA product code for NEX-LINK SPINAL FIXATION SYSTEM OFFSET CONNECTORS, 2121-XX SERIES is MNI.

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Other records listing Abbott Spine, Inc. 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.

K090060NEXLINK OCT SYSTEM, MODEL 7000 SERIESK082032SEQUOIA SPINAL SYSTEM (MODEL 3306), SPEEDLINK TRANSVERSE CONNECTOR (MODELS 3308, 3309, 3310)K081622UNIVERSAL CLAMP STAINLESS STEEL SYSTEMK073202ARDIS SPACERK072672SEQUOIA SPINAL SYSTEM, MODEL 3300 SERIESK071174PATHFINDER SYSTEM POLYAXIAL PEDICLE SCREWS

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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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