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FDA 510(k)

TALON SPINAL SYSTEM

K-Number: K102995 · 2011-02-02

ApplicantSpine360
Decision Date2011-02-02
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TALON SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Spine360. It received FDA 510(k) clearance on 2011-02-02 under 510(k) number K102995. 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 TALON SPINAL SYSTEM?

TALON SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2011-02-02. The listed applicant is Spine360. The 510(k) number is K102995.

When did TALON SPINAL SYSTEM receive FDA 510(k) clearance?

TALON SPINAL SYSTEM received FDA 510(k) clearance on 2011-02-02, under 510(k) number K102995.

Who is the listed applicant for TALON SPINAL SYSTEM?

The FDA 510(k) record lists Spine360 as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TALON SPINAL SYSTEM?

The FDA product code for TALON SPINAL SYSTEM is MNI.

Related Clinical Trials

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.

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Other records listing Spine360 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.

K092531SPINE360 ANTERIOR CERVICAL PLATE SYSTEM

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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