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510(k) K191210

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 2020
Date Received
May 6, 2019
Clearance Type
Traditional
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

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  • 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)
  • K170410 — Longeviti PMMA Static Cranial Implant (March 23, 2018)

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  • K214109 — PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) (October 28, 2022)
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  • 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)