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FDA 510(k)

LIFE SPINE INTERSPINOUS FIXATION SYSTEM

K-Number: K100407 · 2010-11-05

ApplicantLife Spine
Decision Date2010-11-05
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LIFE SPINE INTERSPINOUS FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Life Spine. It received FDA 510(k) clearance on 2010-11-05 under 510(k) number K100407. 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 LIFE SPINE INTERSPINOUS FIXATION SYSTEM?

LIFE SPINE INTERSPINOUS FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2010-11-05. The listed applicant is Life Spine. The 510(k) number is K100407.

When did LIFE SPINE INTERSPINOUS FIXATION SYSTEM receive FDA 510(k) clearance?

LIFE SPINE INTERSPINOUS FIXATION SYSTEM received FDA 510(k) clearance on 2010-11-05, under 510(k) number K100407.

Who is the listed applicant for LIFE SPINE INTERSPINOUS FIXATION SYSTEM?

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

What is the FDA product code for LIFE SPINE INTERSPINOUS FIXATION SYSTEM?

The FDA product code for LIFE SPINE INTERSPINOUS FIXATION SYSTEM is MNI.

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Other records listing Life Spine 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.

K182470Plateau Spacer SystemK160169The Life Spine Subtalar Implant SystemK131077LIFE SPINE PLATEAU SPACER SYSTEMK123373NAUTILUS SPINAL SYSTEMK120998SOLSTICE CROSS CONNECTORK111953NAUTILUS SPINAL SYSTEM

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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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