• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Recognition List Number: 034 FR Publication Date: 01/30/2014 

Part B: Supplementary Information

Recognition Number 8-354: ASTM F1377-13, standard specification for cobalt-28 chromium-6 molybdenum powder for coating of orthopedic implants (uns r30075). (Materials)

Date of Standard: 2013. 
Address of Standards Development Organization:
 ASTM International (ASTM)
  100 Barr Harbor Drive
  West Conshohocken, PA 19428-2959
 
CDRH Offices and Divisions associated with recognized standards:
(1)OFFICE OF DEVICE EVALUATION (ODE)
(2)OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Metallic Porous Coatings on Implants
Processes Affected:
510(K), IDE, PMA, PDP, HDE, Design Controls
Type of Standard:
 National, Horizontal
Extent of Recognition:
Complete Standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
Unclassified Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Class 3 MBD
§872.3640 Implant, Endosseous, Root-Form Class 2 DZE
§872.3940 Joint, Temporomandibular, Implant Class 3 LZD
§872.3950 Glenoid Fossa Prosthesis Class 3 MPI
§872.3960 Mandibular Condyle Prosthesis Class 3 MPL
§888.3358 Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Class 2 LPH
§888.3358 Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Class 2 MBL
§888.3565 Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Class 2 MBH
FDA Technical Contacts:
 David M. Saylor
  FDA/CDRH/OSEL
  10903 New Hampshire Avenue Building 64, Room 3076
  Silver Spring MD 20993
  301/796-2626
  email: david.saylor@fda.hhs.gov
 Michael J. Ryan (Dental)
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1615
  Silver Spring MD 20993
  301/796-6283
  email: michael.ryan@fda.hhs.gov
-
-