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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 11-207: ASTM F2193-02 (Reapproved 2007), standard specifications and test methods for components used in the surgical fixation of the spinal skeletal system. (Orthopaedics)

Date of Standard: 2002. 
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:
Metallic spinal screw, metallic spinal plate and metallic spinal rod components intended for posterior (interlaminal), anterior/anteriolateral (intervertebral body), and posterior (pedicle) fixation.
Processes Affected:
510(k), HDE, IDE, PMA, PDP, Design Controls
Type of Standard:
 Test Methods, National, Vertical
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
Unclassified Orthosis, Cervical Pedicle Screw Spinal Fixation   NKG
§888.3050 Appliance, Fixation, Spinal Interlaminal Class 2 KWP
§888.3060 Appliance, Fixation, Spinal Intervertebral Body Class 2 KWQ
§888.3070 Orthosis, Spinal Pedicle Fixation Class 2 MNI
§888.3070 Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease Class 3 NKB
§888.3070 Orthosis, Spondylolisthesis Spinal Fixation Class 2 MNH
Relevant Guidance:
Guidance for Industry and FDA Staff Spinal System 510(k)s, May 3, 2004

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
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