Recognition List Number: 029 Publication Date: 08/20/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 11-243: ASTM F2346-05 (Reapproved 2011), Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs. (Orthopaedics)
Date of Standard: 2005. |
| Address of Standards Organization: |
| ASTM International (ASTM) |
| 100 Barr Harbor Drive |
| West Conshohocken, PA 19428-2959 |
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) |
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| Devices Affected: |
| This standard contains test methods for total artificial disc replacements |
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| Processes Affected: |
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| Type of Standard: |
| Vertical, National, Test Methods |
| Extent of Recognition: |
Complete standard
This standard describes static and fatigue test methods for total artificial disc replacements. The methods described may not be sufficient to characterize all mechanical aspects of the device being tested. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| Unclassified |
Prosthesis, Intervertebral Disc |
Class 3 |
MJO |
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| Relevant Guidance: |
Guidance for Industry and FDA Staff - Preparation and Review of Investigational Device Exemption Applications (IEs) for Total Artificial Discs, April 11, 2008
Guidance for Industry and/or FDA Reviewers/Staff - Guidance Document for the Preparation of IDEs for Spinal Systems, January 13, 2000 |
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| FDA Technical Contact: |
| Jonathan Peck |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 1418 |
| Silver Spring MD 20993 |
| 301/796-5650 |
| Email: jonathan.peck@fda.hhs.gov |
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