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510(k) K161446

Biopor Porous Polyethylene Implants by Ceremed , Inc. — Product Code GWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2016
Date Received
May 25, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Cranioplasty, Preformed, Alterable
Device Class
Class II
Regulation Number
882.5320
Review Panel
NE
Submission Type

Other clearances by Ceremed , Inc.

  • 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)
  • K082245 — AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AOC-LV (September 18, 2008)

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