Medpor Plus Orbital Volume Replacement Impant

• • Terminated Z-1435-2012 FDA Not yet classified ·initiated 20 Mar 2012

  The MEDPOR PLUS SST EZ 22mm sphere implants are not within specification of 22mm +/- 8, therefore implant is not easily released from the syringe.

510(k) Number

K021357 ↗

FDA Product Code

HPZ

Device Class

Class II

Regulation

21 CFR Part 886.3320

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• Medpor Surgical Granule Implants

  Class II

  FDA 510(k) K982040 Active Cleared 8 Sep 1998

• Porex Nostril Retainers

  Class I

  FDA 510(k) K981374 Active Cleared 2 Jul 1998

• Medpor Quad Motility Implant

  Class II

  FDA 510(k) K010902 Active Cleared 19 Jun 2001

• Medpor Surgical Implant Material

  Class II

  FDA 510(k) K943275 Active Cleared 2 Sep 1994

• Medpor Craniofacial Implants with Embedded Titanium Mesh

  Class II

  FDA 510(k) K040364 Active Cleared 30 Jun 2004

• Porex Electrosurgery Needle

  Class II

  FDA 510(k) K052297 Active Cleared 28 Mar 2006

See all devices from Porex Surgical, Inc. →