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FDA 510(k)

SYNTHES DUAL-OPENING USS

K-Number: K020517 · 2002-04-15

ApplicantSynthes (Usa)
Decision Date2002-04-15
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTHES DUAL-OPENING USS is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 2002-04-15 under 510(k) number K020517. 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 DUAL-OPENING USS?

SYNTHES DUAL-OPENING USS is a medical device that received FDA 510(k) clearance on 2002-04-15. The listed applicant is Synthes (Usa). The 510(k) number is K020517.

When did SYNTHES DUAL-OPENING USS receive FDA 510(k) clearance?

SYNTHES DUAL-OPENING USS received FDA 510(k) clearance on 2002-04-15, under 510(k) number K020517.

Who is the listed applicant for SYNTHES DUAL-OPENING USS?

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

What is the FDA product code for SYNTHES DUAL-OPENING USS?

The FDA product code for SYNTHES DUAL-OPENING USS is MNI.

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Other records listing Synthes (Usa) 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.

K121601SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATEK120854SYNTHES VA LCP ANKLE TRAUMA SYSTEMK120717SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)K120070SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEMK120083SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN)K111667SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS

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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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