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510(k) K083621

MEDPOR CUSTOMIZED SURGICAL IMPLANT by Porex Surgical, Inc. — Product Code JOF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 2009
Date Received
December 8, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Polymer, Ent Synthetic, Porous Polyethylene
Device Class
Class II
Regulation Number
874.3620
Review Panel
EN
Submission Type

Other clearances by Porex Surgical, Inc.

  • K102184 — MEDPOR CONTAIN CAN IMPLANT (January 7, 2011)
  • K101835 — MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079 (December 3, 2010)
  • K091807 — MEDPOR FIXATION SYSTEM (June 28, 2010)
  • K091120 — MEDPOR CONTAIN IMPLANT (March 19, 2010)
  • K071335 — MEDPOR ATTRACTOR IMPLANT (August 8, 2007)
  • K052297 — POREX ELECTROSURGERY NEEDLE (March 28, 2006)
  • K040851 — MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEM (July 16, 2004)
  • K040364 — MEDPOR CRANIOFACIAL IMPLANTS WITH EMBEDDED TITANIUM MESH (June 30, 2004)
  • K021357 — MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT (August 5, 2002)
  • K012350 — MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL (March 14, 2002)

Other clearances for product code JOF

  • K200532 — StarPore (June 2, 2020)
  • K171037 — PoreStar Patient Specific Implant (December 27, 2017)
  • K002629 — SILMAX CONTOUR CARVING BLOCK IMPLANT (November 20, 2000)
  • K771726 — BIOSPONGE STAPES PISTON (September 26, 1977)
  • K771727 — BIOSPONGE RECONSTRUCTION DISCS (September 26, 1977)