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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 031 FR Publication Date: 08/05/2013 

Part B: Supplementary Information

Recognition Number 8-340: ASTM F2026-12, standard specification for polyetheretherketone (peek) polymers for surgical implant applications. (Materials)

Date of Standard: 2012. 
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:
Implantable Medical Devices
Processes Affected:
510(k), PMA, IDE, PDP, Design Controls
Type of Standard:
 National, Vertical
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§888.3030 Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Class 2 KTT
§888.3030 Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Class 2 LXT
§888.3030 Appliance, Fixation, Nail/Blade/Plate Combination, Single Component Class 2 KTW
§888.3030 Appliance, Nail/Blade/Plate Combination, Single Component Class 2 KWK
§888.3030 Condylar Plate Fixation Implant Class 2 JDP
§888.3030 Device, Fixation, Proximal Femoral, Implant Class 2 JDO
§888.3030 Plate, Fixation, Bone Class 2 HRS
§888.3040 Screw, Fixation, Bone Class 2 HWC
§888.3060 Spinal Vertebral Body Replacement Device Class 2 MQP
§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 Document for Testing Non-Articulating, 'Mechanically Locked,' Modular Implant Components, May 1, 1995

Guidance for Industry and/or FDA Staff: Guidance Document for the Preparation of IDEs for Spinal Systems, January 13, 2000

Guidance for Industry and FDA Staff: Spinal System 510(k)s, May 3, 2004

Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Intervertebral Body Fusion Device, June 12, 2007
FDA Technical Contact:
 Hany Demian
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1528
  Silver Spring MD 20993
  301/796-6420
  email: hany.demian@fda.hhs.gov
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