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510(k) K161052

OsteoFab Patient Specific Facial Device by Oxford Performance Materials, Inc. — Product Code KKY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 2016
Date Received
April 14, 2016
Clearance Type
Special
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 Oxford Performance Materials, Inc.

  • K190915 — OsteoFab Suture Anchors (July 3, 2019)
  • K180064 — OsteoFab Patient Specific Cranial Device (July 27, 2018)
  • K142005 — SpineFab Vertebral Body Replacement (VBR) System (July 10, 2015)
  • K133809 — OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE (July 28, 2014)
  • K121818 — OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE (February 7, 2013)

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  • 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)