• 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) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back To Search Results
Recognition List Number: 036 FR Publication Date: 07/09/2014 

Part B: Supplementary Information

Recognition Number 11-278: ASTM F1717-14, standard test methods for spinal implant constructs in a vertebrectomy model. (Orthopaedics)

Date of Standard: 2014. 
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:
Devices Affected:
This standard contains test methods for spinal implant assemblies in a vertebrectomy model. Devices commonly tested using the methods described in this standard include: pedicle and/or lateral mass screw systems, hook systems, and anterior and lateral plating systems.
Processes Affected:
510(k), IDE, PMA, HDE
Type of Standard:
 International, Test Methods, Vertical
Extent of Recognition:
Complete Standard
Related CFR Citations and Product Codes:
Device Name Device
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
  10903 New Hampshire Avenue Building 66, Room 1418
  Silver Spring MD 20993
  email: jonathan.peck@fda.hhs.gov