HPZ · Class II · 21 CFR 886.3320

FDA Product Code HPZ: Implant, Eye Sphere

Leading manufacturers include Porex Surgical, Inc., Oculo Plastik, Inc. and Fci (France Chirurgie Instrumentation) Sas.

39
Total
39
Cleared
126d
Avg days
1978
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Implant, Eye Sphere Devices (Product Code HPZ)

39 devices
1–24 of 39
Cleared Jun 24, 2022
EZYPOR
K212741
Fci (France Chirurgie Instrumentation) Sas
Ophthalmic · 298d
Cleared Jan 31, 2013
DURETTE OCULAR IMPLANT
K123764
Oculo Plastik, Inc.
Ophthalmic · 55d
Cleared Nov 02, 2011
BIOCERAMIC ORBITAL IMPLANT, ORBTEX
K110554
Ceramisys, Ltd.
Ophthalmic · 247d
Cleared Sep 15, 2011
SILICONE SPHERES
K112176
Oculo Plastik, Inc.
Ophthalmic · 49d
Cleared Mar 19, 2008
DURETTE IMPLANT
K073293
Oculo Plastik, Inc.
Ophthalmic · 117d
Cleared Aug 08, 2007
MEDPOR ATTRACTOR IMPLANT
K071335
Porex Surgical, Inc.
Ophthalmic · 89d
Cleared Apr 19, 2007
ORBITAL RECONSTRUCTIVE IMPLANT
K070130
Becker & Associates Consulting, Inc.
Ophthalmic · 93d
Cleared May 09, 2006
ALPHASPHERE ORBITAL IMPLANT
K053298
Hydron Pty Limited
Ophthalmic · 165d
Cleared Jul 16, 2004
MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEM
K040851
Porex Surgical, Inc.
Ophthalmic · 107d
Cleared Aug 05, 2002
MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT
K021357
Porex Surgical, Inc.
Ophthalmic · 98d
Cleared Jun 19, 2001
MEDPOR QUAD MOTILITY IMPLANT
K010902
Porex Surgical, Inc.
Ophthalmic · 85d
Cleared Apr 19, 2000
BIOCERAMIC ORBITAL IMPLANT
K992294
Fci Ophthalmics, Inc.
Ophthalmic · 287d
Cleared Dec 28, 1998
BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER
K982562
Integrated Orbital Implants, Inc.
Ophthalmic · 158d
Cleared Oct 16, 1997
MOA BONE / M-SPHERE
K972143
Iop, Inc.
Ophthalmic · 132d
Cleared Oct 03, 1997
EYE SPHERE, CONFORMERS
K972661
Gulden Ophthalmics
Ophthalmic · 79d
Cleared Aug 22, 1996
GORE SPHEREX IMPLANT
K962241
W.L. Gore & Associates, Inc.
Ophthalmic · 72d
Cleared May 29, 1996
MEDPOR OCULAR PEG SYSTEM AND ACCESSORIES
K960859
Porex Technologies Corp. of Georgia
Ophthalmic · 89d
Cleared Jan 25, 1996
MEDPOR OCULAR SCREW & ACCESSORIES
K954939
Porex Surgical, Inc.
Ophthalmic · 87d
Cleared Sep 02, 1994
MEDPOR SURGICAL IMPLANT MATERIAL
K943275
Porex Surgical, Inc.
Ophthalmic · 57d
Cleared Mar 30, 1992
STERILE/SINGLE USE EYE SPHERE IMPLANTS
K921106
Storz Instrument Co.
Ophthalmic · 21d

About Product Code HPZ - Regulatory Context

510(k) Submission Activity

39 total 510(k) submissions under product code HPZ since 1978, with 39 receiving FDA clearance (average review time: 126 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.