Recognition List Number: 025 Publication Date: 10/04/2010
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 11-214: ASTM F 382-99 (Reapproved 2008)e1, Standard Specification and Test Method for Metallic Bone Plates. (Orthopaedics)
Date of Standard: 2008. |
| 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: |
| Metallic Bone Plates for orthopedic use |
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| Processes Affected: |
| 510(K), PMA, IDE, PDP, HDE, Design Controls |
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| Type of Standard: |
| International, Test Methods, Vertical |
| Extent of Recognition: |
Complete Standard
This test method applies to the static bend testing of metallic bone plates to determine strength equivalent bending stiffness and ductility. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3030 |
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component |
Class 2 |
KTT |
| §888.3030 |
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite |
Class 2 |
LXT |
| §888.3030 |
Appliance, Fixation, Nail/Blade/Plate Combination, Single Component |
Class 2 |
KTW |
| §888.3030 |
Appliance, Nail/Blade/Plate Combination, Single Component |
Class 2 |
KWK |
| §888.3030 |
Condylar Plate Fixation Implant |
Class 2 |
JDP |
| §888.3030 |
Plate, Fixation, Bone |
Class 2 |
HRS |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.4540 |
Bender |
Class 1 |
HXW |
| §888.4540 |
Instrument, Bending Or Contouring |
Class 1 |
HXP |
| |
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| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
|
| FDA Technical Contact: |
| Ronald Jean |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 1414 |
| Silver Spring MD 20993 |
| 301/796-5650 |
| Email: ronald.jean@fda.hhs.gov |
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