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510(k) K211514

Longeviti PorousFit implant by Longeviti Neuro Solutions, LLC — Product Code KKY

K211514 is an FDA 510(k) premarket notification submitted by Longeviti Neuro Solutions, LLC for the device "Longeviti PorousFit implant". The FDA issued a decision of Substantially Equivalent on July 15, 2021. The device falls under product code KKY (Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction), a Class II device regulated under 21 CFR 878.3500. Longeviti Neuro Solutions, LLC has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2021
Date Received
May 17, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Device Class
Class II
Regulation Number
878.3500
Review Panel
SU
Submission Type

Other clearances by Longeviti Neuro Solutions, LLC

  • K260709 — ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit (June 25, 2026)
  • K231920 — Longeviti ClearFit OTS Cranial Implant (November 9, 2023)
  • 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)
  • 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)

Other clearances for product code KKY

  • K161052 — OsteoFab Patient Specific Facial Device (July 20, 2016)
  • K160988 — Biopor, AOC Porous Polyethylene, Cerepor (July 14, 2016)
  • K141880 — BIOPOR AOC POROUS POLYETHYLENE, CEREPOR (April 16, 2015)
  • K133809 — OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE (July 28, 2014)
  • K140437 — SU-POR SURGICAL IMPLANT (June 13, 2014)
  • K133046 — OMNIPORE CUSTOMIZED SURGICAL IMPLANTS (May 14, 2014)
  • K123908 — OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES (July 31, 2013)
  • K111323 — SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS (November 16, 2011)
  • K103010 — STRYKER PATIENT SPECIFIC POLYMER IMPLANT (October 26, 2010)
  • K080507 — AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLA (April 21, 2008)

FDA data resources