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510(k) K080507

AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT by Ceremed , Inc. — Product Code KKY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 2008
Date Received
February 25, 2008
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 Ceremed , Inc.

  • K161446 — Biopor Porous Polyethylene Implants (September 27, 2016)
  • K160988 — Biopor, AOC Porous Polyethylene, Cerepor (July 14, 2016)
  • K141880 — BIOPOR AOC POROUS POLYETHYLENE, CEREPOR (April 16, 2015)
  • K132198 — ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI (September 12, 2013)
  • K122561 — ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN (November 27, 2012)
  • K120220 — ADAPTAIN SOLUBLE IMPLANT MATERIAL (June 6, 2012)
  • K103047 — CERETENE SOLUBLE IMPLANT MATERIAL (January 5, 2011)
  • K102071 — OSTENE CT, AOC CT, OSTEOTENE, CERETENE (October 8, 2010)
  • K091636 — OSTENE CT, AOC CT, OSTEOTENE, CERETENE (June 22, 2009)
  • K082491 — OSTENE CT SOLUBLE BONE HEMOSTASIS IMPLANT MATERIAL, AOC CT, AOC, OSTENE, OSTEOTE (September 24, 2008)

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)
  • 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)