Recognition List Number: 025 Publication Date: 10/04/2010
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 11-210: ASTM F 543-07e1, Standard Specification and Test Methods for Metallic Medical Bone Screws. (Orthopaedics)
Date of Standard: 2007. |
| 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 screws (non-spinal applications) |
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| Processes Affected: |
| 510(K), PMA, IDE, PDP, HDE, Design Controls |
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| Type of Standard: |
| International, Vertical, Test Methods |
| Extent of Recognition: |
Complete Standard
The specification standard provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws implanted into bone tissue. As the specification standard states, the dimensions and tolerances are applicable only to metallic bone screws described in the specification itself. 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 |
Plate, Fixation, Bone |
Class 2 |
HRS |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3040 |
Pin, Fixation, Threaded |
Class 2 |
JDW |
| |
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| Relevant Guidance: |
| Reviews Guidance Checklist for Orthopedic External Fixation Devices Version #5, 2/21/97 |
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| 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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