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U.S. FDA Medical Device Intraoral Ligature and Wire Lock Requirements: Intraoral Ligature and Wire Lock

FDA Medical Device Definition: An intraoral ligature and wire lock is a metal device intended to constrict fractured bone segments in the oral cavity. The bone segments are stabilized by wrapping the ligature (wire) around the fractured bone segments and locking the ends together

Registrar Corp assists Intraoral Ligature and Wire Lock companies with:

  • FDA Intraoral Ligature and Wire Lock Establishment Registration
  • FDA Intraoral Ligature and Wire Lock Listing
  • FDA Intraoral Ligature and Wire Lock Label Requirements and Exceptions
  • FDA Intraoral Ligature and Wire Lock Import Information
  • FDA Intraoral Ligature and Wire Lock Detentions (Intraoral Ligature and Wire Lock Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Intraoral Ligature and Wire Lock Manufacturers (Intraoral Ligature and Wire Lock Suppliers)
       - Intraoral Ligature and Wire Lock Distributors
       - Intraoral Ligature and Wire Lock Processors
       - Intraoral Ligature and Wire Lock Repackers
       - Intraoral Ligature and Wire Lock Relabelers
       - Intraoral Ligature and Wire Lock Exporters
       - Intraoral Ligature and Wire Lock Importers
For more information about Intraoral Ligature and Wire Lock Medical Devices, simply click below:




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U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.


Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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