Recognition List Number: 022 Publication Date: 09/08/2009
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 8-185: ASTM F451-08, Standard Specification for Acrylic Bone Cement. (Materials)
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: |
| Medical Devices Containing or Consisting of Acrylic Bone Cement |
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| Processes Affected: |
| 510(K), PMA, IDE, PDP, HDE, Design Controls |
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| Type of Standard: |
| National, Horizontal |
| Extent of Recognition: |
Complete Standard
Refer to the appropriate biocompatibility standards for specific biocompatibility requirements. Additional information must be provided to document that the design of the product will provide adequate mechanical properties for the specific application. Depending on the device application, additional material property data (such as fatigue life, wear and abrasion resistance) may be required beyond what is addressed by this standard. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3027 |
Bone Cement |
Class 2 |
LOD |
| §888.3027 |
Bone Cement, Antibiotic |
Class 2 |
MBB |
| §888.3027 |
Cement, Bone, Vertebroplasty |
Class 2 |
NDN |
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| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
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| FDA Technical Contact: |
| Hany Demian |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 1528 |
| Silver Spring MD 20993 |
| 301/796-6420 |
| Email: hany.demian@fda.hhs.gov |
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