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510(k) K040364

MEDPOR CRANIOFACIAL IMPLANTS WITH EMBEDDED TITANIUM MESH by Porex Surgical, Inc. — Product Code FTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2004
Date Received
February 13, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
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)
  • K083621 — MEDPOR CUSTOMIZED SURGICAL IMPLANT (February 3, 2009)
  • K071335 — MEDPOR ATTRACTOR IMPLANT (August 8, 2007)
  • K052297 — POREX ELECTROSURGERY NEEDLE (March 28, 2006)
  • K040851 — MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEM (July 16, 2004)
  • K021357 — MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT (August 5, 2002)
  • K012350 — MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL (March 14, 2002)

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