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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 030 FR Publication Date: 01/15/2013 

Part B: Supplementary Information

Recognition Number 11-251: ASTM F2554-10, standard practice for measurement of positional accuracy of computer assisted surgical systems. (Orthopaedics)

Date of Standard: 2010. 
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:
Stereotactic, surgical navigation and robotic positioning systems
Processes Affected:
510(k), PMA, IDE, HDE, de novo
Type of Standard:
 National
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§882.4560 Neurological Stereotaxic Instrument Class 2 HAW
§882.4560 Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri Class 2 ORR
§882.4560 Orthopedic Stereotaxic Instrument Class 2 OLO
§882.4560 Patient Specific Manual Orthopedic Stereotaxic System Class 2 OSF
FDA Technical Contact:
 Dwight Yen
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1432
  Silver Spring MD 20993
  301/796-6401
  email: dwight.yen@fda.hhs.gov
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