Recognition List Number: 030 Publication Date: 01/15/2013
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 11-203: ASTM F1541-02 (Reapproved 2011)e1, Standard Specification and Test Methods for External Skeletal Fixation Devices. (Orthopaedics)
Date of Standard: 2002. |
| 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: |
| External skeletal fixation devices |
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| Processes Affected: |
| 510(k), IDE, HDE, PMA, PDP, Design Controls |
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| Type of Standard: |
| International, Test Methods, Vertical |
| Extent of Recognition: |
Complete Standard.
Test methods provide examples of acceptable types of test setups and methods for the characterization of external skeletal fixation devices. Additional information should be provided to document deviations from the standard as well as to document that the design of the product will provide adequate mechanical properties for the particular application. Additional testing may be required for external skeletal fixation devices for novel intended uses as well as external skeletal fixation devices that contain novel materials. |
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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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