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Device
prosthesis, intervertebral disc
Review Panel
Orthopedic
Product Code
MJO
Premarket Review
Office of Orthopedic Devices
(OHT6)
Spinal Devices (DHT6B)
Submission Type
PMA
Device Class
3
Total Product Life Cycle (TPLC)
TPLC Product Code Report
GMP Exempt?
No
Summary Malfunction
Reporting
Eligible
Implanted Device?
Yes
Life-Sustain/Support Device?
No
Recognized Consensus Standards
8-195 ASTM F2024-10 (Reapproved 2016)
Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
11-185 ASTM F2267-04 (Reapproved 2018)
Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
11-269 ASTM F2423-11 (Reapproved 2020)
Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
11-274 ISO 18192-2 First edition 2010-06-15
Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 2: Nucleus replacements
11-343 ASTM F2346-18
Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs
11-351 ISO 18192-1 Second edition 2011-03-01
Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test [Including AMENDMENT 1 (2018)]
11-353 ISO 18192-3 First edition 2017-06
Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 3: Impingement-wear testing and corresponding environmental conditions for test of lumbar prostheses under adverse kinematic conditions
11-354 ASTM F3295-18
Standard Guide for Impingement Testing of Total Disc Prostheses
11-369 ASTM F3292-19
Standard Practice for Inspection of Spinal Implants Undergoing Testing
Third Party Review
Not Third Party Eligible
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