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- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- HPZImplant, Eye Sphere2Product Code
- K212741EZYPOR2Cleared 510(K)
- K123764DURETTE OCULAR IMPLANT2Cleared 510(K)
- K110554BIOCERAMIC ORBITAL IMPLANT, ORBTEX2Cleared 510(K)
- K112176SILICONE SPHERES2Cleared 510(K)
- K083342ORBITAL RECONSTRUCTIVE IMPLANT II2Cleared 510(K)
- K082850EYE SPHERES2Cleared 510(K)
- K073293DURETTE IMPLANT2Cleared 510(K)
- K071335MEDPOR ATTRACTOR IMPLANT2Cleared 510(K)
- K070130ORBITAL RECONSTRUCTIVE IMPLANT2Cleared 510(K)
- K053298ALPHASPHERE ORBITAL IMPLANT2Cleared 510(K)
- K040851MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEM2Cleared 510(K)
- K040689EYE SPHERE IMPLANTS2Cleared 510(K)
- K023400FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT2Cleared 510(K)
- K021643HA ORBITAL IMPLANT2Cleared 510(K)
- K021357MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT2Cleared 510(K)
- K010902MEDPOR QUAD MOTILITY IMPLANT2Cleared 510(K)
- K003338BIO-EYE II ORBITAL IMPLANT2Cleared 510(K)
- K992294BIOCERAMIC ORBITAL IMPLANT2Cleared 510(K)
- K982562BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER2Cleared 510(K)
- K972143MOA BONE / M-SPHERE2Cleared 510(K)
- K972661EYE SPHERE, CONFORMERS2Cleared 510(K)
- K962241GORE SPHEREX IMPLANT2Cleared 510(K)
- K960859MEDPOR OCULAR PEG SYSTEM AND ACCESSORIES2Cleared 510(K)
- K954939MEDPOR OCULAR SCREW & ACCESSORIES2Cleared 510(K)
- K941717MARTINEZ HYDROXYLAPATITE ORBITAL IMPLANT2Cleared 510(K)
- K943275MEDPOR SURGICAL IMPLANT MATERIAL2Cleared 510(K)
- K934834EPTFE SHEET COVERING FOR OCULAR IMPLANT2Cleared 510(K)
- K935251MARTINEZ ORBITAL IMPLANT2Cleared 510(K)
- K921106STERILE/SINGLE USE EYE SPHERE IMPLANTS2Cleared 510(K)
- K915630OPHTIMPLANT2Cleared 510(K)
- K911110OPHTA SIL(R), ENULCEATION/EVISCERATION IMPLANTS2Cleared 510(K)
- K900081NEW ALLEN IMPLANT2Cleared 510(K)
- K900080NEW IOWA MOTILITY IMPLANT2Cleared 510(K)
- K895908MULES SPHERE GLASS (SEVERAL SIZES)2Cleared 510(K)
- K891137MOTILITY ORBITAL IMPLANT2Cleared 510(K)
- K873578LEE ALLEN'S UNIVERSAL MOTILITY IMPLANT2Cleared 510(K)
- K863943POREX(TM) EYE SPHERE IMPLANT2Cleared 510(K)
- K862977MEDITRADE ARTIFICIAL EYES AND IMPLANTS2Cleared 510(K)
- K781356IMPLANT, EYE SPHERE2Cleared 510(K)
- HQHEye, Artificial, Non-Custom1Product Code
- HQJImplant, Absorbable, (Scleral Buckling Methods)2Product Code
- HQLIntraocular Lens3Product Code
- HQMKeratoprosthesis, Permanent Implant2Product Code
- HQNConformer, Ophthalmic2Product Code
- HQTShell, Scleral2Product Code
- HQWClip, Tantalum, Ophthalmic2Product Code
- HQXImplant, Orbital, Extra-Ocular2Product Code
- KYFImplant, Eye Valve2Product Code
- MFKLens, Multifocal Intraocular3Product Code
- MJPLens, Intraocular, Toric Optics3Product Code
- MLPKeratoprosthesis, Temporary Implant, Surgical Use2Product Code
- MQUOcular Peg2Product Code
- MTZWrap, Implant, Orbital2Product Code
- NAALens, Intraocular, Accommodative3Product Code
- NCKButton, Iris, Eye, Artificial1Product Code
- NFMExpander, Tissue, Orbital2Product Code
- NIZLens, Iris Reconstruction3Product Code
- NQBConformer, Ophthalmic, Biological Tissue2Product Code
- NXMProsthesis, Eyelid Spacer/Graft, Biologic2Product Code
- POEExtended Depth Of Focus Intraocular Lens3Product Code
- PUFOcular Peg, Exempt2Product Code
- PZKLight Adjustable Lens (Lal) And Light Delivery Device (Ldd)3Product Code
- QCBPhakic Toric Intraocular Lens3Product Code
- QWUProsthesis, Eyelid Spacer/Graft, Polymer2Product Code
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
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EYE SPHERE IMPLANTS
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K040689
- 510(k) Type
- Traditional
- Applicant
- Oculo Plastik, Inc.
- Country
- Canada
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/10/2004
- Days to Decision
- 86 days
- Submission Type
- Statement