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Product Classification

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Device

prosthesis, intervertebral disc

Review Panel

Orthopedic

Product Code

MJO

Submission Type

PMA

Device Class

3

Total Product Life Cycle (TPLC)

TPLC Product Code Report

GMP Exempt?

No

Recognized Consensus Standards

ASTM F2024-10 Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
ASTM F2267-04 (Reapproved 2011) Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
ASTM F2346-05 (Reapproved 2011) Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs

Third Party Review

Not Third Party Eligible

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