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510(k) K891137

MOTILITY ORBITAL IMPLANT by Integrated Orbital Implants, Inc. — Product Code HPZ

K891137 is an FDA 510(k) premarket notification submitted by Integrated Orbital Implants, Inc. for the device "MOTILITY ORBITAL IMPLANT". The FDA issued a decision of Substantially Equivalent on August 24, 1989. The device falls under product code HPZ (Implant, Eye Sphere), a Class II device regulated under 21 CFR 886.3320. Integrated Orbital Implants, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 1989
Date Received
March 3, 1989
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.

  • K003338 — BIO-EYE II ORBITAL IMPLANT (February 7, 2001)
  • 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)

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