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FDA 510(k)

SYNAPSE SYSTEM

K-Number: K070573 · 2007-06-08

ApplicantSynthes Spine Co.Lp
Decision Date2007-06-08
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNAPSE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Synthes Spine Co.Lp. It received FDA 510(k) clearance on 2007-06-08 under 510(k) number K070573. 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 SYNAPSE SYSTEM?

SYNAPSE SYSTEM is a medical device that received FDA 510(k) clearance on 2007-06-08. The listed applicant is Synthes Spine Co.Lp. The 510(k) number is K070573.

When did SYNAPSE SYSTEM receive FDA 510(k) clearance?

SYNAPSE SYSTEM received FDA 510(k) clearance on 2007-06-08, under 510(k) number K070573.

Who is the listed applicant for SYNAPSE SYSTEM?

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

What is the FDA product code for SYNAPSE SYSTEM?

The FDA product code for SYNAPSE SYSTEM is MNI.

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Other records listing Synthes Spine Co.Lp 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.

K121852SYNTHES ZERO-P VARIABLE ANGLE (VA)K112459SYNTHES ZERO-PK112068SYNTHES ZERO-P VARIABLE ANGLE (VA)K103320SYNTHES XRLK081568ANTEGRA-TK080020ARCOFIX

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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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