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Product Classification

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Device

appliance, fixation, spinal interlaminal

Regulation Description

Spinal interlaminal fixation orthosis.

Regulation Medical Specialty

Orthopedic

Review Panel

Orthopedic

Product Code

KWP

Submission Type

510(k)

Regulation Number

888.3050

Device Class

2

Total Product Life Cycle (TPLC)

TPLC Product Code Report

GMP Exempt?

No

Recognized Consensus Standards

ASTM F1798-97(Reapproved 2008) Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
ASTM F 983-86 (Reapproved 2009) Standard Practice for Permanent Marking of Orthopaedic Implant Components
ASTM F 565-04 (Reapproved 2009)e1 Standard Practice for Care and Handling of Orthopedic Implants and Instruments
ASTM F2706-08 Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebretomy Model
ASTM F1717-12 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
ASTM F2193-02(2007) Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System

Third Party Review

Not Third Party Eligible

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