| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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047
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Date of Entry 08/21/2017
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FR Recognition Number
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11-175
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| Standard | |
ASTM F1582-98 (Reapproved 2016)
Standard Terminology Relating to Spinal Implants |
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Scope/Abstract| 1.1 This terminology covers basic terms and considerations for spinal implant devices and their mechanical analyses. |
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| Extent of Recognition
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Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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Public Law, CFR Citation(s) and Procode(s)*
| This standard is potentially related to any spinal implant, spinal regulation or spinal product code |
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Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff - Preparation and Review of Investigational Device Exemption Applications (IDEs) for Total Artificial Discs, April 11, 2008
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Intervertebral Body Fusion Device, June 12, 2007
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
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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| FDA Technical Contact
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
