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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 8-123: ISO 5832-5 Third edition 2005-10-15, implants for surgery -- metallic materials -- part 5: wrought cobalt-chromium-tungsten-nickel alloy. (Materials)

Date of Standard: 2005. 
Address of Standards Development Organization:
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
  SWITZERLAND
CDRH Offices and Divisions associated with recognized standards:
(1)OFFICE OF DEVICE EVALUATION (ODE)
(2)OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Implantable Medical Devices
Processes Affected:
510(K), PMA, IDE, PDP, HDE, Design Controls
Type of Standard:
 International, Horizontal
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§872.3645 Implant, Subperiosteal Class 2 ELE
§872.3940 Joint, Temporomandibular, Implant Class 3 LZD
§872.3950 Glenoid Fossa Prosthesis Class 3 MPI
§872.3960 Mandibular Condyle Prosthesis Class 3 MPL
§872.4600 Lock, Wire, And Ligature, Intraoral Class 2 DYX
§872.4760 External Mandibular Fixator And/Or Distractor Class 2 MQN
§872.4760 Implant, Transmandibular Class 2 MDL
§872.4760 Plate, Bone Class 2 JEY
§872.4880 Screw, Fixation, Intraosseous Class 2 DZL
No product code information listed for §888.3XXX, METALLIC COMPONENTS OF ALL IMPLANTABLES
FDA Technical Contacts:
 John Goode (Orthopaedics)
  FDA/CDRH/ODE/DGRND
  9200 CORPORATE BLVD, HFZ-410
  ROCKVILLE MD 20850
  240/276-3676
  email: JOHN.GOODE@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
* in the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036
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