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510(k) K203349

Longeviti ClearFit Cranial Implant by Longeviti Neuro Solutions, LLC — Product Code GXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2020
Date Received
November 13, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Cranioplasty, Preformed, Non-Alterable
Device Class
Class II
Regulation Number
882.5330
Review Panel
NE
Submission Type

Other clearances by Longeviti Neuro Solutions, LLC

  • K231920 — Longeviti ClearFit OTS Cranial Implant (November 9, 2023)
  • K212058 — Longeviti ClearFit™ OTS Cranial Implants (September 8, 2021)
  • K211514 — Longeviti PorousFit implant (July 15, 2021)
  • K210616 — Longeviti PMMA Static Cranial Implant (March 31, 2021)
  • K202901 — Longeviti ClearFit Cranial Implant (October 30, 2020)
  • K191210 — Longeviti ClearFit Cranial Implant (January 9, 2020)
  • K170410 — Longeviti PMMA Static Cranial Implant (March 23, 2018)

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  • K231920 — Longeviti ClearFit OTS Cranial Implant (November 9, 2023)
  • K214109 — PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) (October 28, 2022)
  • K220357 — MedCAD AccuShape Titanium Patient-Specific Cranial Implant (August 26, 2022)
  • K210099 — Meticuly Patient-Specific Titanium Mesh Implant (December 21, 2021)
  • K212058 — Longeviti ClearFit™ OTS Cranial Implants (September 8, 2021)
  • K210616 — Longeviti PMMA Static Cranial Implant (March 31, 2021)