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Product Classification

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Device

screw, fixation, bone, non-spinal, metallic

Regulation Description

Smooth or threaded metallic bone fixation fastener.

Regulation Medical Specialty

Orthopedic

Review Panel

Orthopedic

Product Code

NDJ

Submission Type

510(k)

Regulation Number

888.3040

Device Class

2

Total Product Life Cycle (TPLC)

TPLC Product Code Report

GMP Exempt?

No

Recognized Consensus Standards

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 F543-07 Standard Specification and Test Methods for Metallic Medical Bone Screws
ASTM F1839-08e2 Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments

Third Party Review

Not Third Party Eligible

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