Home / 510(k) Clearances / K133046

510(k) K133046

OMNIPORE CUSTOMIZED SURGICAL IMPLANTS by Matrix Surgical Holdings, LLC/Matrix Surgical USA — Product Code KKY

K133046 is an FDA 510(k) premarket notification submitted by Matrix Surgical Holdings, LLC/Matrix Surgical USA for the device "OMNIPORE CUSTOMIZED SURGICAL IMPLANTS". The FDA issued a decision of Substantially Equivalent on May 14, 2014. The device falls under product code KKY (Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction), a Class II device regulated under 21 CFR 878.3500. Matrix Surgical Holdings, LLC/Matrix Surgical USA has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2014
Date Received
September 27, 2013
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 Matrix Surgical Holdings, LLC/Matrix Surgical USA

  • K180249 — OmniPore DUROMAX Surgical Implants (October 11, 2018)

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)
  • 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