Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 11-227: ASTM F 366-10, Standard Specification for Fixation Pins and Wires. (Orthopaedics)
Date of Standard: 2010. |
| 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: |
| Smooth or threaded fixation pins and wires used with or without external skeletal fixation devices. |
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| Processes Affected: |
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| Type of Standard: |
| International, Test Methods, Vertical |
| Extent of Recognition: |
Complete Standard.
Standard covers functional dimensions and considerations for the characterization and comparison of external skeletal fixation devices. Additional information must be provided to document that the design of the product will provide adequate mechanical properties for the particular application. |
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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 |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3040 |
Pin, Fixation, Smooth |
Class 2 |
HTY |
| §888.3040 |
Pin, Fixation, Threaded |
Class 2 |
JDW |
| |
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| Relevant Guidance: |
| Reviewers Guidance Checklist for Orthopedic External Fixation Devices Version #5, 2/21/97 |
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| FDA Technical Contact: |
| Michael Kasser |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 1576 |
| Silver Spring MD 20993 |
| 301/796-6946 |
| Email: michael.kasser@fda.hhs.gov |
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