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510(k) K123908

OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES by Matrix Surgical USA — Product Code KKY

K123908 is an FDA 510(k) premarket notification submitted by Matrix Surgical USA for the device "OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on July 31, 2013. The device falls under product code KKY (Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction), a Class II device regulated under 21 CFR 878.3500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2013
Date Received
December 19, 2012
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 for product code KKY

  • K211514 — Longeviti PorousFit implant (July 15, 2021)
  • 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)
  • 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