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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 034 FR Publication Date: 01/30/2014 

Part B: Supplementary Information

Recognition Number 8-226: ASTM F603-12, standard specification for high-purity dense aluminum oxide for medical application. (Materials)

Date of Standard: 2012. 
Address of Standards Development Organization:
 ASTM International (ASTM)
  100 Barr Harbor Drive
  West Conshohocken, PA 19428-2959
 
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Femoral Head and Acetabular Liner Components of Total Hip Replacements (THR), Abutments for Endosseus Dental Implants
Processes Affected:
510(k), IDE, HDE, PMA, PDP, Design Controls
Type of Standard:
 Vertical, National
Extent of Recognition:
Complete Standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
Unclassified Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented Class 3 LPF
Unclassified Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented Class 3 MRA
§872.3630 Abutment, Implant, Dental, Endosseous Class 2 NHA
§888.3353 Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Class 2 OQI
§888.3353 Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish Class 2 MAY
§888.3353 Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Class 2 LZO
§888.3410 Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer Class 3 KXB
§888.3410 Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented Class 3 OCG
Relevant Guidance:
Guidance Document for the Preparation of Premarket Notification For Ceramic Ball Hip Systems, January 10, 1995.

Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments ? Guidance for Industry and FDA Staff, May 12, 2004.
FDA Technical Contact:
 Peter Allen
  FDA/CDRH/ODE
  10903 New Hampshire Building 66, Room 1512
  Silver Spring MD 20993
  301/796-6402
  email: peter.allen@fda.hhs.gov
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