• 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 11-243: ASTM F2346-05 (Reapproved 2011), standard test methods for static and dynamic characterization of spinal artificial discs. (Orthopaedics)

Date of Standard: 2005. 
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:
This standard contains test methods for total artificial disc replacements
Processes Affected:
PMA, IDE
Type of Standard:
 Vertical, National, Test Methods
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
Unclassified Prosthesis, Intervertebral Disc Class 3 MJO
Relevant Guidance:
Guidance for Industry and FDA Staff - Preparation and Review of Investigational Device Exemption Applications (IEs) for Total Artificial Discs, April 11, 2008

Guidance for Industry and/or FDA Reviewers/Staff - Guidance Document for the Preparation of IDEs for Spinal Systems, January 13, 2000
FDA Technical Contact:
 Jonathan Peck
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1418
  Silver Spring MD 20993
  301/796-5650
  email: jonathan.peck@fda.hhs.gov
-
-