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FDA 510(k)

Optima ZS Transition Screw

K-Number: K071880 · 2007-10-05

ApplicantZimmer Spine, Inc.
Decision Date2007-10-05
Product CodeMNI
Advisory CommitteeOR
DecisionUnknown

Device Summary

Optima ZS Transition Screw is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Spine, Inc.. It received FDA 510(k) clearance on 2007-10-05 under 510(k) number K071880. The device is classified under product code MNI. It was reviewed by the OR advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the Optima ZS Transition Screw?

Optima ZS Transition Screw is a medical device that received FDA 510(k) clearance on 2007-10-05. The listed applicant is Zimmer Spine, Inc.. The 510(k) number is K071880.

When did Optima ZS Transition Screw receive FDA 510(k) clearance?

Optima ZS Transition Screw received FDA 510(k) clearance on 2007-10-05, under 510(k) number K071880.

Who is the listed applicant for Optima ZS Transition Screw?

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

What is the FDA product code for Optima ZS Transition Screw?

The FDA product code for Optima ZS Transition Screw is MNI.

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Other records listing Zimmer Spine, Inc. 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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