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FDA 510(k)

ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM

K-Number: K093170 · 2009-11-04

ApplicantSpineart
Decision Date2009-11-04
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Spineart. It received FDA 510(k) clearance on 2009-11-04 under 510(k) number K093170. 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 ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM?

ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM is a medical device that received FDA 510(k) clearance on 2009-11-04. The listed applicant is Spineart. The 510(k) number is K093170.

When did ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM receive FDA 510(k) clearance?

ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM received FDA 510(k) clearance on 2009-11-04, under 510(k) number K093170.

Who is the listed applicant for ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM?

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

What is the FDA product code for ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM?

The FDA product code for ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM is MNI.

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Other records listing Spineart 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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