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510(k) K010902

MEDPOR QUAD MOTILITY IMPLANT by Porex Surgical, Inc. — Product Code HPZ

K010902 is an FDA 510(k) premarket notification submitted by Porex Surgical, Inc. for the device "MEDPOR QUAD MOTILITY IMPLANT". The FDA issued a decision of Substantially Equivalent on June 19, 2001. The device falls under product code HPZ (Implant, Eye Sphere), a Class II device regulated under 21 CFR 886.3320. Porex Surgical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 2001
Date Received
March 26, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Eye Sphere
Device Class
Class II
Regulation Number
886.3320
Review Panel
OP
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)
  • K040364 — MEDPOR CRANIOFACIAL IMPLANTS WITH EMBEDDED TITANIUM MESH (June 30, 2004)
  • K021357 — MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT (August 5, 2002)

Other clearances for product code HPZ

  • K212741 — EZYPOR (June 24, 2022)
  • K123764 — DURETTE OCULAR IMPLANT (January 31, 2013)
  • K110554 — BIOCERAMIC ORBITAL IMPLANT, ORBTEX (November 2, 2011)
  • K112176 — SILICONE SPHERES (September 15, 2011)
  • K083342 — ORBITAL RECONSTRUCTIVE IMPLANT II (March 12, 2009)
  • K082850 — EYE SPHERES (February 27, 2009)
  • K073293 — DURETTE IMPLANT (March 19, 2008)
  • K071335 — MEDPOR ATTRACTOR IMPLANT (August 8, 2007)
  • K070130 — ORBITAL RECONSTRUCTIVE IMPLANT (April 19, 2007)
  • K053298 — ALPHASPHERE ORBITAL IMPLANT (May 9, 2006)

FDA data resources