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FDA 510(k)

SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEM

K-Number: K984612 · 1999-01-19

ApplicantSynthes Spine
Decision Date1999-01-19
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Synthes Spine. It received FDA 510(k) clearance on 1999-01-19 under 510(k) number K984612. 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 SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEM?

SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEM is a medical device that received FDA 510(k) clearance on 1999-01-19. The listed applicant is Synthes Spine. The 510(k) number is K984612.

When did SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEM receive FDA 510(k) clearance?

SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEM received FDA 510(k) clearance on 1999-01-19, under 510(k) number K984612.

Who is the listed applicant for SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEM?

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

What is the FDA product code for SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEM?

The FDA product code for SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEM is MNI.

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Other records listing Synthes 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.

K122211SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTSK120838SYNTHES MATRIX SYSTEMK111048SYNTHES SCOUT TACK FIXATIONK120928SYNTHES MATRIX SYSTEMK120571SYNTHES USS CONNECTORK113149SYNTHES USS CONNECTORS

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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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