Home / 510(k) Clearances / K003338

510(k) K003338

BIO-EYE II ORBITAL IMPLANT by Integrated Orbital Implants, Inc. — Product Code HPZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2001
Date Received
October 25, 2000
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 Integrated Orbital Implants, Inc.

  • K000151 — PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE (April 10, 2000)
  • K982562 — BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER (December 28, 1998)
  • K974203 — PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM (February 4, 1998)
  • K891137 — MOTILITY ORBITAL IMPLANT (August 24, 1989)

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)