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510(k) K231920

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 2023
Date Received
June 29, 2023
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

  • 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)
  • K203349 — Longeviti ClearFit Cranial Implant (December 16, 2020)
  • 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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  • K212058 — Longeviti ClearFit™ OTS Cranial Implants (September 8, 2021)
  • K210616 — Longeviti PMMA Static Cranial Implant (March 31, 2021)
  • K203349 — Longeviti ClearFit Cranial Implant (December 16, 2020)