Recognition List Number: 026 Publication Date: 03/18/2011
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 11-168: ASTM F1781-03 (Reapproved 2009), Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants. (Orthopaedics)
Date of Standard: 2003. |
| 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: |
| Test methods for characterization and comparison of silicone elastomer finger prostheses. |
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| Processes Affected: |
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| Type of Standard: |
| National, Vertical, Test Methods |
| Extent of Recognition: |
Complete standard.
Standard covers design, material, and test methods for the characterization and comparison of elastomeric finger prosthesis. Additional information must be provided to document that the design of the product will provide adequate mechanical properties for the particular application. In applications subjected to wear or articulation, additional data must be provided to document resistance to wear and abrasion. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3230 |
Prosthesis, Finger, Constrained, Polymer |
Class 2 |
KYJ |
| §888.3230 |
Prosthesis, Finger, Polymer |
Class 2 |
KWF |
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| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
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| FDA Technical Contact: |
| John Goode |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 1510 |
| Silver Spring MD 20993 |
| 301/796-6407 |
| Email: john.goode@fda.hhs.gov |
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