Instrument SMUI-KSM

Trade Name

Instrument

Generic Name

Instrument tray, reusable

Model / Ref / Catalog

SMUI-KSM, SMUI-12

Primary DI / UDI-DI

05060296236441

FDA Product Code

FSM

GMDN Term

Instrument tray, reusable

Device Class

Class I

Regulation Number

878.4800

GUDID distribution status

Not in Commercial Distribution

Sterilization Method

Moist Heat or Steam Sterilization

• Jts Extendeable Implant

  Class II

  FDA 510(k) K092138 Active Cleared 22 Mar 2011

• Jts Extendible Distal Femoral Implant

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  FDA 510(k) K133152 Active Cleared 22 Jan 2014

• Patient Specific Distal Femoral Open recall

  Class II

  FDA 510(k) K140898 Active Cleared 20 Jan 2015

• Mets Modular Total Femur

  Class II

  FDA 510(k) K121055 Active Cleared 19 Sep 2012

• Mets Modular Proximal Femur

  Class II

  FDA 510(k) K121056 Active Cleared 20 Sep 2012

• Sculptor Robotic Guidance Arm (RGA)

  Class II

  FDA 510(k) K121765 Active Cleared 11 Jan 2013

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